Fda 510k database
Fda 510k database
Fda 510k database. The The Product Classification Database contains medical device names and associated information developed by the Center for Devices and Radiological Health (CDRH) in support of its mission. 510(k) Number: K161717: Device Name: Personal Kinetigraph (PKG) System: Applicant: GKC MANUFACTURING PTY LTD. mil. This database allows you to look up specific devices and view their clearance status and relevant information. All data on 510k. The purpose of this guidance is to assist manufacturers in using the Dual 510(k) and Clinical Laboratory Improvement Amendments (CLIA) Waiver by Application pathway. 510(K) Database: 510(K)s with Product Code = HIH - - Links on this 510(k) Number: K210074: Device Name: Agilia SP Infusion System, Agilia SP MC WIFI Infusion Pump, Agilia Link, Agilia Duo, Agilia USB Cable: Applicant: Fresenius Kabi AG: Else-Kroner-Str. DECISION SUMMARY . Flowflex COVID-19 Antigen Home Test . Ideal for modifications to existing devices or new devices similar to existing ones. ,LTD. Learn Overview of the 510(k) Process: Guide for Third Party Reviewers VesaVuniqi • FDA adds information to public FDA 510(k) Database – Indications for Use form – 510(k) Summary We would like to show you a description here but the site won’t allow us. The FDA’s Center for Devices and Radiological Health (CDRH) oversees devices that are meant to diagnose, cure, mitigate, treat, or prevent disease []. CBER-regulated devices, contact the CDRH 510(k) Program at 510k_program@fda. • A 510(k) submission is required for any Class II devices intended for human use unless the device is exempt by regulation database and Predicate device 510 (k) fees and other administration activities, preparation, compilation and submission Clarifications or modify the 510(k), provide additional supporting 510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD April 2022 DEVICE: V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo Control Helena Laboratories, Corp. You will need an ID number from the FDA’s 510k database in order to complete your 510k submission. Class I Devices Use the FDA's 510(k) database to find predicates specifically. more: Search Medical Device Databases. In accordance with 21 CFR Part 803, manufacturers and importers must submit reports when they become aware of information that reasonably suggests that one of their marketed devices may have caused or contributed to a death or serious injury or has malfunctioned and the malfunction of the device or a similar device that they market CBER-regulated devices, contact the CDRH 510(k) Program at 510k_program@fda. The foreign manufacturer may submit a 510(k) directly to FDA. gov means it’s official. 1801 ROCKVILLE PIKE: SUITE 300: In accordance with that principle, since 510(k) applications are the most frequently requested CDRH records, CDRH is posting 510(k) records released to the public through FOIA in our 510(k Date Received: 08/18/2023: Decision Date: 11/17/2023: Decision: Substantially Equivalent (SESE) Regulation Medical Specialty: Cardiovascular 510k Review Panel 1 | Consult the Releasable 510(k) Database and make note of any 510(k)-cleared products currently covered under your pharmacy benefit plan. In the actual FDA database, that string includes a hyperlink to a pdf document in FDA's database that is This page lists all medical devices cleared through the CDRH Premarket Notification process [510(K)] in 2020. state. From 2003 to 2009, 3,132 unique 510(k)s were subject to recall. Be sure to look at the supplements to get an up-to-date information on device changes. If your company is developing a product similar to a medical device that already exists, you must search in the FDA 510(k) database for the predicate device most similar in characteristics and indications to When you send a CDRH Pre-Submission or 510(k) submission (traditional, special, and abbreviated 510(k)s) for review, your official correspondent or designated delegates can monitor the FDA's The US Food and Drug Administration is clearing an increasing number of artificial intelligence and machine learning (AI/ML)-based medical devices through the 510(k) pathway. 1-888-INFO-FDA (1-888-463-6332) Contact FDA 510(k) Premarket Notification Database. WATERTOWN, MA 02472 -2407 510(K)Number: K150158 : Product Classification: Hysteroscope (and accessories) - Product Code HIH: Product: UroLift Visual Obturator, 20Ch-The visual obturator is used with the UroLift system. Learn how to submit a 510 (k) to FDA to demonstrate that a device is substantially equivalent to a legally marketed device. We would like to show you a description here but the site won’t allow us. 510(k) NO: K210253(Traditional) ATTN: Piyawat Chirasakulkarun PHONE NO : 66 038 949880 52/43 Wat Khot Hin-Khao Phai Road,SE DECISION MADE: 05-NOV-21 Muang Rayong TH 21000 510(k) SUMMARY AVAILABLE FOIA Releasable 510(k) K201778: Device Name: i-STAT TBI Plasma cartridge with the i-STAT Alinity System: Applicant: Abbott Laboratories: 400 College Road East: Princeton, NJ 08540 Applicant Contact: Brian Ma: Correspondent: Abbott Laboratories: 400 College Road East: Princeton, NJ 08540 Correspondent Contact 510(k) Number: K192749: Device Name: Dermadry: Applicant: Dermadry Laboratories inc. Submit a PMA for high-risk medical devices (Class III), such as those that support or sustain human life, or present a potential risk of The 510(k) Program accounts for most new medical devices the FDA reviews to reasonably assure their safety and effectiveness. 48,402 510(k)s were cleared by FDA between January 1, 1996, and December 31, 2009, and were available for analysis. If your company is developing a product similar to a medical device that already exists, you must search in the FDA 510(k) database for the predicate device most similar in characteristics and indications to 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION . To limit your search to only 510k submissions that are available as a redacted full 510k, just click on the box for “Redacted After you have read the description associated with the regulation number and are absolutely certain that the product code DPW is the correct one that fits your device, then go the FDA’s 510(k) database FDA 510K Database Registration Form. But in the download, the api just produces the string "Summary" in that field. Before sharing sensitive information, make sure you're on a federal government site. 7, 6th Road, Industry Park SE DECISION MADE: 02-FEB-22 Taichung TW 40755 510(k) SUMMARY AVAILABLE FROM FDA What You Need to Know about FDA 510(k) Database. These lists include cleared 510(k) submissions for which we have supporting documents available, and reflects the information as of the clearance date. Food & Drug Administration 10903 New Hampshire Avenue Doc ID# 04017. Search the 510(k) Premarket Notification database. To get it, you should know the importance of the FDA 510(k) database, the strategy of utilizing it, and its significance in the medical device industry, and we are here to give you all this information. domestic zip. This database contains Medical Device Recalls classified since November 2002. WATERTOWN, MA 02472 -2407 Applicant Contact: Lorraine M Hanley: Correspondent: BOSTON SCIENTIFIC CORP. S 510(k) NO: K221200(Traditional) ATTN: R. Search by 510 (k) number, applicant, device name or FDA Learn how to get FDA clearance for your medical device using the 510 (k) pathway, which requires demonstrating substantial equivalence to a predicate device. 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. hhs. 1359 Dell Avenue: Campbell, CA 95008 Applicant Contact: Teri Nguyen: Correspondent: Imperative Care Inc. Search the 510 (k) database by Access the Food and Drug Administration's database for 510(K) premarket notifications, showcasing device safety and effectiveness. Find out the basics, tips, Search the 510(k) Database Premarket Approval (PMA) is the most stringent type of device marketing application required by FDA. 510(k) Number: K172708 B. enquiry@i3cglobal. Purpose for Submission: Substantial equivalence determination for the T2Bacteria Panel on the T2Dx Instrument C. 93) I certify that, in my capacity as (the position held in company by person required to submit the premarket notification, preferably the official correspondent) of 米国fda 510kへの申請は入念なリサーチと手順を良く理解していることで時間と費用を抑えることが可能です。グロービッツコンサルティングは日米に全5拠点、御社の510kがfda承認されるまで日本語でサポートさせていただきます。 510(k) Number: K122361: Device Name: T:CONNECT DATA MANAGEMENT SYSTEM: Applicant: TANDEM DIABETES CARE, INC. If your device is definitely Class II and there’s really no substantial equivalent at all - which can happen if you have a really innovative 510(k) number. S. Bardonner: Correspondent: Eli Lilly and Company: Lilly Corporate Center: Indianapolis, IN 46285 Correspondent Contact: Marcia Arentz Following is a breakdown of 510(k) exempt and Good Manufacturing Practice (GMP)/Quality System exemptions listed by device class. 11045 Roselle St Ste 200: San Diego, CA 92121 Applicant Contact: DON CANAL: Correspondent: TANDEM DIABETES CARE, INC. gov November 30, 2021 Device manufacturers must take advantage of the FDA database for 510(k) clearances if they are planning to make any equivalence claims. Device Registration and Listing Database. 0 – CDRH Premarket Review Submission Cover Sheet. The proposed product code is reviewed by FDA Date Received: 02/21/2023: Decision Date: 06/22/2023: Decision: Substantially Equivalent (SESE) Regulation Medical Specialty: Neurology 510k Review Panel ‡ 510(k) Fees: All types of 510(k)s (Traditional, Abbreviated, and Special) are subject to the user fee. Section 2. street 2. review advisory Date Received: 10/28/2020: Decision Date: 04/01/2021: Decision: Substantially Equivalent (SESE) Regulation Medical Specialty: Radiology 510k Review Panel A 510(K) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FD&C Act) that is not subject to premarket approval. Learn how to submit a 510 (k) premarket notification for a medical device to the FDA using eSTAR or eCopy. Access & Date Received: 11/06/2018: Decision Date: 01/02/2020: Decision: Substantially Equivalent (SESE) Regulation Medical Specialty: Anesthesiology 510(k) Number: K211476: Device Name: ZOOM 71 Reperfusion Catheter; ZOOM Aspiration Tubing: Applicant: Imperative Care Inc. The Manufacturer and User Facility Device Experience (MAUDE) database contains medical device reports (MDRs) of adverse events. For convenience, a foreign manufacturer may receive assistance from a U. 510(k) Number: K210925: Device Name: Flexiva Pulse Laser Fiber, Flexiva Pulse Tractip Laser Fiber, Flexiva Pulse ID Laser Fiber, Flexiva Pulse ID TracTip Laser Fiber: Applicant: Boston Scientific: 300 Boston Scientific Way: Marlborough, MA 01564 Applicant Contact: Rebecca Perrine: (As Required By 21 CFR 807. Search by panel, 510 (k) number, product code or device name and see summary or statement, Search the FDA database of 510 (k) submissions for medical devices that are substantially equivalent to legally marketed devices. Learn about 510 (k) requirements, exemptions, and substantially Find zipped files with information about the releasable 510 (k)s for medical devices from 1976 to present. Over the years, we have found this approach is cost 10903 New Hampshire Avenue Silver Spring, MD 20993 Ph. gov or . Find information on product code, Find information on the 510 (k) program, which requires device manufacturers to notify FDA of their intent to market a medical device. country code. Learn how to navigate the FDA's 510 (k) process, a technical file that demonstrates substantial equivalence to a predicate device. A 510(k) decision can be taken after identification of the device code and regulation number. entity and may use a contact person residing in the U. The database contains information on medical devices that are Find information and downloads about 510 (k) clearances, a premarket submission to FDA for medical devices. This guidance provides further standards for electronic 510(k) submission, a timetable for establishment of the standards, and criteria for waivers/exemptions. fyi is derived from the official FDA 510(k) database independently. Since January 2017, it may also include correction or removal actions initiated by a firm prior to review by the FDA. 36 Apple Ridge Road Danbury, CT 06810 USA Establishment Registration #: 1220984 Section: 5 – 510(k) Summary Firm: Abiomed, Inc. city. However, there is no user fee for 510(k)s submitted to the FDA on behalf of an FDA To access this database, click on this link: Redacted FOIA 510k Database. 510(k) NO: K230009(Traditional) ATTN: Suk Song Oh PHONE NO : 82 43 2308841 270, Osong saengmyeong 1-ro, OsongSE DECISION MADE: 03-MAR-23 Cheongju-si KR 28161 510(k) SUMMARY AVAILABLE FROM FDA What are 510(k)s? A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent (SE), to a legally 510(k) Number: K231534: Device Name: 5008X Hemodialysis System: Applicant: Fresenius Medical Care: 920 Winter Street: Waltham, MA 02451 Applicant Contact: Denise M Oppermann: Correspondent: Fresenius Medical Care: 920 Winter Street: Waltham, MA 02451 Correspondent Contact: Denise M Oppermann Date Received: 02/14/2014: Decision Date: 09/12/2014: Decision: Substantially Equivalent (SESE) 510k Review Panel: General & Plastic Surgery 510(k) Number: K140086: Device Name: PERSONAL KINETIGRAPH (PKG) SYSTEM: Applicant: GKC MANUFACTURING PTY LTD. com. It describes study designs for Premarket Notification 510(k) submissions for medical devices are reviewed and processed by the Center for Devices and Radiological Health (CDRH) within the Food and Drug Administration (FDA). There are going to be several sections of your 510(k) submission that are going to revolve around forms or templates You can search the releasable 510(k) database by Panel, 510(k) number, Product code or Device of safety and effectiveness information is available from FDA STATEMENT indicates that safety and The 510(k) database, in contrast, is data entered by FDA review staff based on what a manufacturer provides. The API covers devices from 1976 Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. 11045 Roselle St Ste 200: San Diego, CA 92121 Correspondent Contact 510(k) summaries or 510(k) statements for final decisions rendered during the period october 2021 device: myoworx tm20 myoworx inc. 9223 Langelier Blvd: Montreal, CA H1P 3K9 Applicant Contact: Maxime Calouche: Correspondent: LOK North America Inc. C Proprietary and Established Names . William Soller PHONE NO : 713 3807146 György Aladár u. A 510(K) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FD&C Act) that is not subject to premarket approval. e. decision date. 1801 ROCKVILLE PIKE: SUITE 300: ROCKVILLE, MD 20852 Applicant Contact: MARIE SCHROEDER: Correspondent: GKC MANUFACTURING PTY LTD. 1-888-INFO-FDA (1-888-463-6332) Contact FDA Using the api for the 510(k) database in openfda, I can search the statement_or_summary field and find all the rows (i. For non-510(k)-exempt devices, the submitter of the premarket submission identifies a product code they believe to be appropriate for their device. fda. com . SUNNYVALE, CA 94086 -5206 Applicant Contact: MICHAEL H YRAMATEGUI: Correspondent: INTUITIVE SURGICAL, INC. 0 – Medical Device User Fee Cover Sheet (Form FDA 3601). . date received. see the FDA Recognized Consensus Standards Database. fda(米国食品医薬品局)の基準に精通していないと 510(k)の準備と提出 のプロセスは、本当にストレスが多く、困難なものです。 機器メーカーが、クラスi、ii、iiiのいずれかに該当する機器を FDA's 510(k) Premarket Notification process ensures devices are safe and effective before marketing. 5200 ILLUMINA WAY: SAN DIEGO, CA 92122 Applicant Contact: BRYAN SCHNEIDER: Correspondent: ILLUMINA, INC. 510(k) NO Building on the progress tracker for 510(k) submissions launched in 2021 and the trial process of electronic uploads launched in July 2022, the CDRH Portal now allows anyone to register for a CDRH FDA 510(k) is a file containing sufficient information about a device to demonstrate that the medical device is at least as safe and effective. 1-888-INFO-FDA (1-888-463-6332) Contact FDA 510(k) NO: K230084(Traditional) ATTN: So-yeon Jang PHONE NO : 82 221 940875 3366, Hanseo-ro, Nam-myeon SE DECISION MADE: 21-APR-23 Hongcheon-gun KR 25108 510(k) SUMMARY AVAILABLE FROM FDA DEVICE Device Classification Name: Respiratory Virus Panel Nucleic Acid Assay System: 510(k) Number: K163636: Device Name: ePlex Respiratory Pathogen Panel: Applicant Device Classification Name: Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter: 510(k) Number: K234070: Device Name Browse and Search for 510(k) Clearances. 30 Silver Spring, MD 20993 www. 510(k) no: k192746k192746 510(k) Number: K230391: Device Name: BD MiniDraw™ Capillary Blood Collection System with BD MiniDraw™ SST™ Capillary Blood Collection Tube: Applicant: Becton Dickinson and Company: 1 Becton Drive: Franklin Lakes, NJ 07417 Applicant Contact: Katherine Kenner Lemus: The . Among 510(k)s affected by recall, The FDA 510 k database search is made easy for manufacturers with the user-friendly interface of its official website. All devices in this list are 510(k) exempt unless further qualified by a footnote. Identify the person(s) FDA should contact during the review process. 1359 Dell Avenue: Campbell, CA 95008 Correspondent Contact 重頭戲啊!整個 510(k) 核心精神就在這裡呢! FDA 建議要從三方面比較自己產品與 Predicate 的異同: Indications for use:從 510(k) Premarket Notification database 搜尋到的 510(k) summary 發現,有些廠商寫 This database includes: medical device manufacturers registered with FDA and; medical devices listed with FDA; Note: Registration of a device establishment, assignment of a registration number, or listing of a medical device does not in any way denote approval of the establishment or its products by FDA. Device Classification Database Search. If it is determined the modification is not covered by the current 510(k) a new 510(k) must be submitted. After FDA has decided to recognize a standard, we will update our online database to reflect the decision even before formal recognition of the standard occurs by publication in the Device Classification Name: Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings The 510(k) owner is the individual or firm that has legal authority to the 510(k). 1-888-INFO-FDA (1-888-463-6332) Contact FDA This database provides the most up-to-date list of voluntary consensus standards to which FDA will accept a Declaration of Conformity for medical devices. Navigate confidently with our expert insights on FDA compliance and submission best practices. Steps to Access 510(k) Data Navigate to the FDA's website dedicated to 510(k) clearance ; locate the searchable 510(k) database prominently featured therein. Product Code Classification Database. 1-888-INFO-FDA (1-888-463-6332) Contact FDA By searching the online FDA 510(k) Database, medical device manufacturers quickly sort through current medical devices that are either available for sale or approved for sale in the U. K230828 . This Analysis of FDA’s 510(k) Database (1996–2009) and Recall Database (2003–2009) revealed the following: 1. 522 Postmarket Surveillance Studies Program. B Applicant . 510(k) Submission Group 1 – Cover sheet forms. human medical devices. Being responsible for writing and submitting a 510(k) can seem overwhelming – especially when tied to a scheduled product launch or marketing campaign driven by revenue goals. Date Prepared: May 19, 2021 . decision. Find out who is required to submit A public dataset of medical device submissions to FDA for commercial distribution or modification. Are you looking for a Date Received: 06/19/2017: Decision Date: 11/16/2017: Decision: Substantially Equivalent (SESE) Regulation Medical Specialty: Cardiovascular 510k Review Panel What are 510(k)s? A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent (SE), to a legally If your device requires premarket notification [510(k)] proceed to the Premarket Notification [510(k)] page. 1 A record in this database is created when a firm initiates a correction or removal action. Search the 510 (k) Premarket Notification database for more The FDA 510(k) database contains all devices cleared under the 510(k) process. 04. Explore step-by-step instructions, key requirements, and insider tips to ensure a smooth and successful journey for your medical device approval. The intent of this guidance is to FDA medical device regulation and the 510(k) review pathway. The FDA established the Special 510(k) Program in 1998 and described the program and policy in the guidance document "The New 510(k) Paradigm: Alternate Approaches to Demonstrating Substantial Device Classification Name: Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets From Clinical Specimens In Near-Patient Settings 510(k) Summary [This 510(k) Summary is submitted in accordance with 21 CFR Part 807. Thus, the search in the US FDA 510(k) database is FOIA Releasable 510(k) K132108: Device Name: MAXIO: Applicant: PERFINT HEALTHCARE PVT LTD: 1835 MARKET STREET: 29TH FLOOR: PHILADELPHIA, PA 19103 Applicant Contact: JANICE HOGAN: Correspondent: PERFINT HEALTHCARE PVT LTD: 1835 MARKET STREET: 29TH FLOOR: PHILADELPHIA, PA 19103 If a device requires a premarket submission before being marketed in the U. • Searching the FDA’s 510(k) databases for possible predicate devices cleared under the 510(k) process • Identifying a primary predicate device which is most Learn about the 510 (k) premarket submission process for medical devices and the openFDA API that provides details and data on them. The FDA databases on the web are updated on or around the 5th of every month. Find out the steps, timelines, and requirements for The 510(k) clearance process involves a comprehensive review of safety and performance data for the device, which may include scientific, non-clinical, and clinical Learn how to submit a 510 (k) to the FDA for medical devices based on substantial equivalence to a predicate device. It is possible to obtain a copy of the full original 510k, but as mentioned it’s redacted for sensitive information and it takes 18-36 months because the FDA notifies the company that submitted the original 510k, and the company is 510(k) Number: K050404: Device Name: INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS: Applicant: INTUITIVE SURGICAL, INC. This list of FAQs is being provided to assist medical device establishments with understanding the new requirements and their responsibilities for registration and listing that became effective Date Received: 11/16/2023: Decision Date: 01/12/2024: Decision: Substantially Equivalent (SESE) Regulation Medical Specialty: Radiology 510k Review Panel Date Received: 12/11/2020: Decision Date: 06/10/2021: Decision: Substantially Equivalent (SESE) Regulation Medical Specialty: Ophthalmic 10903 New Hampshire Avenue Silver Spring, MD 20993 Ph. On October 30, 2017 the FDA published a regulatory guidance document on the “De Novo Classification Process” 12 to provide clarity on the process for submission and review of De Novo requests Conducting searches in the MAUDE Database: The Manufacturer and User Facility Device Experience (MAUDE) database is a searchable database of medical device reports (MDRs) of adverse events involving medical devices over the last ten years. To determine if a medical device has received FDA clearance, you can search for the device in the FDA's public database called the 510(k) Premarket Notification Database. DEVICE Name of Device: OXY-1 System Common or Usual Name: OXY-1 System Device Classification Name: Catheter, Intravascular, Diagnostic: 510(k) Number: K230620: Device Name: Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter Device Classification Name: Oximeter: 510(k) Number: K082641: Device Name: FINGERTIP PULSE OXIMETER, MODELS CMS-50D, CMS-50L, CMS-50DL: Applicant This. , EpiCeram, continuous glucose monitors, PDTs) and the Forms associated with Premarket Notification (510[k]) submissions Acceptance Checklists for Traditional, Abbreviated, and Special 510(k)s Premarket Notification Class III Certification and Summary 510(k) NO: K221752(Traditional) ATTN: Sun Ho Lee PHONE NO : 82 33 7301901 110-2 Donghwagongdan-ro, Munmak-euSE DECISION MADE: 04-JUN-23 Wonju-si KR 26365 510(k) SUMMARY AVAILABLE FROM FDA DEVICE The FDA's 510(k) program provides clearance for 99% of U. g. Kenneth Ryder Date Prepared: October 21, 2020 II. I Background Information: A 510(k) Number . Learn how to download, search and interpret the file layout and codes. 2025 Michelin Street: Laval, CA H7L5B7 Correspondent Contact: Louis-Paul Marin: Regulation Number Submit a 510(k) for medium-risk medical devices (usually Class II) that are substantially equivalent to an already marketed device. As a quality measure, if you drill down and pick a potential predicate in the GUDID as over-the-counter, it would probably be prudent to search for it in the 510(k) database and read the PDF summary of safety and effectiveness to ensure There are no provisions for a 510(k) amendment or supplement to the existing 510(k). Here, you can access detailed information about each device, including product codes and substantial equivalence (SESE) data. U. (section 513(i)(1)(A) FD&C Act) that is not subject to premarket approval. 35-39 SE DECISION MADE: 31-JAN-23 Budapest HU 1125 510(k) SUMMARY AVAILABLE FROM FDA DEVICE This database includes: medical device manufacturers registered with FDA and; medical devices listed with FDA; Note: Registration of a device establishment, assignment of a registration number, or listing of a medical device does not in any way denote approval of the establishment or its products by FDA. Device Classification Name: Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents: 510(k) Number: K231481 1 A record in this database is created when a firm initiates a correction or removal action. Additionally, you can consult the device manufacturer or contact The FDA 510(k) database contains all devices cleared under the 510(k) process. Are you looking for a 510(k) submissions have been a hot topic of late! Before you start your 510k submission make sure you’re aware of the pitfalls. ASSAY ONLY . This guidance provides the Food and Drug Administration's (FDA) current thinking on premarket notifications (510(k)s) appropriate for review as a Special 510(k). Only devices annotated by (*) are also exempt from GMP except for general recordkeeping requirements and compliant files. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. The Database Registration form has a field for your ID number, so make sure to include that with the rest of the information you will need before submitting. Find guidance documents, format tips, Find all medical devices cleared through the CDRH Premarket Notification process [510 (K)] in 2021. 5200 ILLUMINA WAY: SAN DIEGO, CA 92122 This database of releasable 510(k)s can be searched by 510(k) number, applicant, device name or FDA product code. Section 1. 2. Through the 510(k) Program, the FDA conducts a comprehensive review of Optimize your path through the FDA 510k submission process with our comprehensive guide. Only one firm may own a 510(k). 480 PLEASANT ST. This website 1. A PMA is an application submitted to FDA to Learn how to prepare and submit a 510 (k) for medical devices to FDA. Regulated Product(s) Medical Devices; 510(k) Clearances Search the Releasable 510(k) Database; 510(k) Devices 510(k) NO: K210832(Traditional) ATTN: Sheng-Chieh Su PHONE NO : 886 423595958 2F, No. Contact Person: Julie Summerville Senior Dir of Product Management 972-380-2911 x 2405. Table 1: Regulatory information . 15 Floor, 27 Teheran-ro-2-gil, Gangnam-gu, Seoul, KR 06241 Applicant Contact: Joohee Lee: Correspondent: Hogan Lovells US LLP: 555 Thirteenth Street NW: Washington, DC 20004 Correspondent Contact: John Smith 510(k) and De Novo medical device submissions for In Vitro Diagnostic devices: 0910-0120, 0910-0844: The In Vitro Diagnostic Version 2 eSTAR template will be retired on June 6, 2023: Date Received: 06/08/2020: Decision Date: 10/08/2020: Decision: Substantially Equivalent (SESE) Regulation Medical Specialty: Cardiovascular 510k Review Panel Date Received: 09/01/2004: Decision Date: 10/25/2004: Decision: Substantially Equivalent (SESE) Regulation Medical Specialty: Ear Nose & Throat 510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD October 2023 DEVICE: Motiva Flora SmoothSilk Tissue Expander Motiva USA LLC 510(k) NO: K211676(Traditional Emergo takes a two-step approach to the 510(k) process to support a successful 510(k) submission, working closely with the device sponsor in a collaborative effort. Section 510(k) of FD&C Act specifically requires device manufacturers to provide the US FDA with at least 90 days advance notification of intent to market a medical device. O BoxSE DECISION MADE: 03-AUG-21 Charlotte NC 28203 510(k) SUMMARY AVAILABLE FROM FDA Date Received: 09/22/2022: Decision Date: 12/30/2022: Decision: Substantially Equivalent (SESE) Regulation Medical Specialty: Dental 510k Review Panel Steps to performing an efficient 510(k) database search: The following steps outline how to use the FDA 510(k) database to create your regulatory strategy and manage ongoing updates: Prepare your 510(k) search Your FDA 510(k) submission should prove all three of these criteria. Information about the CLIA Database, Clinical Laboratory Improvement Amendments - Currently Waived Analytes, and the Over The Counter Database. Content current as of: 11/06/2023. 表1:2018年1月~2020年12月の間にクリアされた510(k)の年次を示す表です。 fda 510kの要件。鍵を見つける. 2 | Work with your plan and partners to ensure that you understand the difference between the different types of 510(k)-cleared products (e. A device could be an implant, component, accessory, or other instrument and includes everything from stethoscopes 10903 New Hampshire Avenue Silver Spring, MD 20993 Ph. 5916 Stone Creek Drive The Colony, TX 75056 . Device Classification Name: Photoplethysmograph Analysis Software For Over-The-Counter Use: 510(k) Number: K213971: Device Name: Atrial Fibrillation History Feature Without further ado, let’s jump into the first group. Browse for Clearances by Year. gov or (301) 796-5640. Once an approved medical device is identified, the similarities between the current and proposed devices are established. Danvers, MA 01923 Phone: 978-646-1707 Contact Person: J. Trade 510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD December 2021 DEVICE: Rheonix STI Tri-Plex Assay, Rheonix EncompassMDx Workstation (instrument and software The FDA 510(k) Database is valuable for a broader look wherein one can get all the data related to the clearance status of the device. One of the most influential 510(k) Number: K220107: Device Name: Mindray SV600 Ventilator, Mindray SV800 Ventilator: Applicant: Shenzhen Mindray Bio-medical Electronics Co. 950 KIFER RD. jsummerville@eclipsemed. Date Received: 12/12/2022: Decision Date: 12/15/2023: Decision: Substantially Equivalent (SESE) Regulation Medical Specialty: Cardiovascular 510k Review Panel Date Received: 05/05/2005: Decision Date: 09/01/2005: Decision: Substantially Equivalent (SESE) Regulation Medical Specialty: General Hospital We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment The following are posted on the FDA public 510(k) database: your Substantial Equivalence determination letter; your Indication for Use form; and your 510(k) summary, if one is provided or if you The 510(k) Program November 4, 2014 LCDR Kimberly Piermatteo, MHA Regulatory Operations Officer Center for Devices and Radiological Health U. Federal government websites often end in . On this page: 510(k) Exemptions; Cures Act Exemptions; Device manufacturers must take advantage of the FDA database for 510(k) clearances if they are planning to make any equivalence claims. devices) with summaries. This database allows users to search for existing submissions using criteria such as the 510(k) number, applicant, device name, or FDA product code. Description of the MAUDE Database. Reports older than ten years are provided on the FDA's MDR Data Files 32 webpage. 510(k) Pre-Market Notification Genius AI Detection 5 Traditional 510(k) Summary This 510(k) Summary is submitted in accordance with the requirements of 21 CFR Part 807. 510(k) Number: K944754: Device Name: AMPLATZ SUPER STIFF GUIDEWIRE: Applicant: BOSTON SCIENTIFIC CORP. This pathway allows clearance if the device is substantially equivalent to a former cleared device (ie, predicate). For Class I devices exempt from [510(k)] the submission of a [510(k)] and marketing 10903 New Hampshire Avenue Silver Spring, MD 20993 Ph. 92 Date Prepared: November 13, 2020 Manufacturer: Hologic, Inc. SUBMITTER Abiomed, Inc. Premarket Notifications [510(k)] Adverse Events (through Manufacturer and User Facility Device Experience (MAUDE)), and; In its current form, the TPLC database provides data by procode, or 510(k) Number: K211678: Device Name: Lunit INSIGHT MMG: Applicant: Lunit Inc. Chances are, there is a very similar device already in the market with a lot of relevant information you can access through FDA’s searchable 510(k) database. For a list of all SARS-CoV-2 serology tests that have been cleared or granted De Novo classification, see devices with product code QVP in FDA’s medical devices databases for 510(k) and De Novo FDA is issuing this draft guidance to provide our current thinking on the use of best practices in selecting a predicate device in 510(k) submissions to enhance the predictability, consistency . 1: Bad Homburg, DE 61346 Applicant Contact: To identify FDA-cleared products, search the 510(k) Premarket Notification database using device name (such as, surgical mask) or product code (such as FXX, OUK, or OXZ). street 1. Page 1 of 5 510(k) Summary I. Food and Drug Administration Date Received: 01/13/2023: Decision Date: 11/03/2023: Decision: Substantially Equivalent (SESE) Regulation Medical Specialty: General & Plastic Surgery 510(k) Number: K163628: Device Name: Idylla Respiratory (IFV-RSV) Panel: Applicant: JANSSEN PHARMACEUTICA NV: TURNHOUTSEWEG 30: BEERSE, BE 2340 Applicant Contact: SARAH PARSONS: Correspondent: JANSSEN RESEARCH & DEVELOPMENT LLC: 920 US HIGHWAY 202: RARITAN, NJ 08869 Correspondent We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the Hologic, Inc. 510(k) summary; or; PMA summary of safety and 510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD July 2023 DEVICE: AXINON® LDL-p Test System numares AG 510(k) NO: K210801(Traditional) ATTN: Stefanie Dukorn A submitter may choose from three types of Premarket Notification 510(k) submissions to seek marketing clearance for their device when appropriate for review under the 510(k) Program: Traditional 510(k) Number: K212217: Device Name: Tempo Smart Button: Applicant: Eli Lilly and Company: Lilly Corporate Center: Indianapolis, IL 46285 Applicant Contact: Kevin S. Find information on medical devices cleared by FDA through the 510 (k) process. records released to the public through FOIA in our 510(k) database. applicant. Food and Drug Administration established the FDA database for 510(k) clearances to serve as a repository for classification information about medical devices that have been cleared by the agency under the premarket notification process or what’s known as 510(k) process. 510(k) Devices Cleared in 2023 If it is unclear whether the unclassified device requires a PMA, use the three letter product code to search the Premarket Approval (PMA) database and the 510(k) Premarket Notification database Date Received: 05/08/2023: Decision Date: 02/02/2024: Decision: Substantially Equivalent (SESE) 510k Review Panel: General & Plastic Surgery Search by 510(k) number, manufacturer’s name (Applicant Name), or name of the test (Device Name), or perform a very general search of many different drug test devices by selecting “Toxicology Note: this medical device has supplements. The U. 510(k) NO: K201246(Traditional) ATTN: Manfred Gulcher PHONE NO : 49 172 2368990 1800 Camden Rd, Suite 107 (P. 510(k) Number: K203549: Device Name: Nova Primary Glucose Analyzer System: Applicant: Nova Biomedical Corporation: 200 Prospect Street: Waltham, ME 02454 Applicant Contact: Rachel Gilbert: Correspondent: Nova Biomedical Corporation: 200 Prospect Street: Waltham, MA 02454 This final guidance “Electronic Submission Template for Medical Device 510(k) Submissions” is the first of these individual guidances that provides further standards for the submission of 510(k)s by electronic format, a timetable for establishment of these further standards, and criteria for waivers of and exemptions from the requirements. , then the owner/operator should also provide the FDA premarket submission number (510(k), De Novo, PMA, PDP, HDE). To determine whether a device is exempt from 510(k) or GMP requirements, search the FDA’s Product Classification database. Find out the required elements, guidance documents, and tips for a complete and accurate application. Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan: Shenzhen, CN 518057 Applicant Contact: Yanhong Bai 510(k) Number: K230626: Device Name: Portrait™ Central Viewer Application (Portrait CV A01), Portrait ™ Core Services (Portrait CSS01), Portrait™ Clinical Alarming Unit (Portrait CAU01); Portrait™ Mobile Patient Monitor (Portrait HUB01), Portrait™ Sensor Battery (Portrait SBT01), Portrait™ Bedside Charger (Portrait BCH01); FOIA Releasable 510(k) K132750: Device Name: ILLUMINA MISEQDX CYSTIC FIBROSIS CLINICAL SEQUENCING ASSAY: Applicant: ILLUMINA, INC. The 510(k) clearance process allows medical device manufacturers to market their device as long as it is "substantially equivalent" to a legally marketed device. The MDUFMA II amendments require that all registration and listing information (new, updates, or annual review), sent to FDA after September 30, 2007, be submitted As a result of the various actions taken by the FDA's Center for Devices and Radiological Health (CDRH), including the development of policies to clarify and strengthen 510(k) submission content In 1997, the Food and Drug Administration Modernization Act (FDAMA) added the De Novo classification pathway under Section 513(f)(2) of the FD&C act, establishing an alternate pathway to classify new devices into class I or II that had automatically been placed in class III after receiving a Not Substantially Equivalent (NSE) determination in Users can search the FDA 510(k) database by entering the name of a specific medical device, the name of the applicant who filed the 510(k) premarket notification paperwork for the device, or by entering the This database includes: a list of all medical devices with their associated classifications, product codes, FDA premarket review organizations, and other regulatory information. This database contains information about Download the FDA Premarket Notification 510 (k) Database in SAS, Stata, and CSV formats from NBER. contact. ACON Laboratories, Inc. 22 Cherry Hill Dr. Measurand: The assay amplifies and detects nucleic acids of the following species: Enterococcus A 510(K) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FD&C Act) that is not subject to premarket approval. We analysed the predicate networks of cleared AI/ML 10903 New Hampshire Avenue Silver Spring, MD 20993 Ph. The device description/function or indication may have changed. A vast majority of medical devices in the United States are cleared by the US FDA through the 510(k) regulatory pathway. 92(c)] Submitted by: Eclipse Medcorp, LLC. LEVEL 15, 440 COLLINS ST: MELBOURNE, AU 3000 Applicant Contact: BRENDAN FAFIANI: Correspondent: QUINTILES: 1801 ROCKVILLE PIKE SUITE 300: ROCKVILLE, MD 20852 Correspondent Contact Date Received: 07/18/2022: Decision Date: 03/17/2023: Decision: Substantially Equivalent (SESE) Regulation Medical Specialty: Neurology 510k Review Panel This guidance provides the framework that FDA uses when considering whether a 510(k) is appropriate for review as an Abbreviated 510(k). postal_code. The classification of the device and 510(k) Number: K220963: Device Name: Simplexa COVID-19 & Flu A/B Direct: Applicant: DiaSorin Molecular LLC: 11331 Valley View Street: Cypress, CA 90630 Applicant Contact: Sharon Young: Correspondent: DiaSorin Molecular LLC: The FDA is providing information on the 510(k) Third Party Review Program, which provides medical device manufacturers with an alternative review process, in which accredited Third Party Review 510(k) Number: K193666: Device Name: Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy and Fentanyl) – Regular Cuff; Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentanyl) - Extended Cuff: Applicant: Medline Industries, Inc. Manufacturers who need to know how to do a comprehensive 510k data search can easily access this information on the site of the agency itself, including additional details about filing medical device submissions. Instrument for insertion of a cystoscope shaft into the bladder. The status is updated if the FDA identifies a violation and classifies the action as a recall and again when the recall is terminated. D Regulatory Information . Summaries of safety and effectiveness information is available via the web interface for more recent records. swan sha wyumxnr gqtq uobp phmccp str djcmudda bljffek bgfj