510 k searchable database. The advanced search will return up to 500 results for MDRs received over the selected timeframe. Find information on medical devices cleared by FDA through the 510 (k) process. Cardiotachometer & Rate Alarm) 510(k) Number: K212143: Device Name: Neteera 130H/131H Vital Sign Monitoring Sensor Date Received: 07/13/2023: Decision Date: 12/08/2023: Decision: Substantially Equivalent (SESE) Regulation Medical Specialty: Dental Date Received: 11/16/2023: Decision Date: 01/12/2024: Decision: Substantially Equivalent (SESE) Regulation Medical Specialty: Radiology Date Received: 03/07/2022: Decision Date: 12/08/2022: Decision: Substantially Equivalent (SESE) Regulation Medical Specialty: Gastroenterology/Urology Sep 9, 2024 · Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links. Date Received: 09/18/2023: Decision Date: 11/01/2023: Decision: Substantially Equivalent (SESE) Regulation Medical Specialty: Gastroenterology/Urology Sep 9, 2024 · Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links. fyi is derived from the official FDA 510(k) database Sep 9, 2024 · This database includes: a list of all medical devices with their associated classifications, product codes, FDA Premarket Review organizations, and other regulatory information. Oct 3, 2022 · If the 510(k) is deleted, the 510(k) submitter will need to submit a new, complete 510(k) to pursue FDA marketing clearance for that device. over a specific timeframe. 510(k) Number: K233358: Device Name: SCoV-2 Ag Detect Rapid Test: Sep 9, 2024 · Date Received: 09/01/2004: Decision Date: 10/25/2004: Decision: Substantially Equivalent (SESE) Regulation Medical Specialty: Ear Nose & Throat Nov 6, 2023 · This page lists all medical devices cleared through the CDRH Premarket Notification process [510(K)] in 2021. Please narrow your search. Search the 510 (k) database by year or download zipped files, or browse for clearances by year. A PMA is an application submitted to FDA to request approval to market. 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 specific 510(k) number or product code associated with a given device. Introduction. Only FDA generated product codes will work with the 510(k) and other FDA databases. Content current as of: 02/07/2024. Product Code. Instead, they specify which actions, such as introducing a device to the U. S. For additional information, please visit the FDA's Premarket Notification 510(k) page. Search the FDA database of 510 (k) submissions for medical devices that are substantially equivalent to legally marketed devices. This Nov 1, 2022 · The 510(k) database, in contrast, is data entered by FDA review staff based on what a manufacturer provides. Typically, they will add new devices around the 5th of each month for devices cleared in the prior month. single size tendon spacer: * The maximum 500 records meeting your search criteria returned. Nov 6, 2023 · Search the Releasable 510(k) Database; 510(k) Devices Cleared in 2023; 510(k) Devices Cleared in 2022 Search the 510(k) Premarket Notification database. 510(k)s for similar device types are usually linked in the 510(k) database by the same product code. Once accepted, a 510(k) proceeds to the Substantive Review. Feb 7, 2024 · December 2023 510(k) Clearances (database) Search the 510(k) Premarket Notification database. Search by panel, 510 (k) number, product code or device name and see summary or statement, decision, classification and more. Sep 9, 2024 · Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links. Nov 6, 2023 · Find medical devices that have been cleared by FDA through the 510 (k) program, which requires device manufacturers to notify FDA of their intent to market a device at least 90 days in advance. Content current as of: 11/06/2023 Sep 2, 2024 · Device Classification Name: Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) 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 Sep 9, 2024 · Date Received: 12/18/2023: Decision Date: 09/05/2024: Decision: Substantially Equivalent (SESE) Regulation Medical Specialty: Radiology Sep 9, 2024 · Date Received: 05/08/2023: Decision Date: 02/02/2024: Decision: Substantially Equivalent (SESE) 510k Review Panel: General & Plastic Surgery Sep 9, 2024 · Date Received: 07/18/2022: Decision Date: 03/17/2023: Decision: Substantially Equivalent (SESE) Regulation Medical Specialty: Neurology 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. The U. 180 days to rectify the shortcomings and submit information against the deficiencies. 510(k) Statement. Sep 9, 2024 · 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. Find information on product code, center, applicant name, decision date and more. Regulated Product(s) Medical Devices; 510(k) Clearances The FDA's 510(k) program provides clearance for 99% of U. Advanced search allows a user to search on specific fields such as device brand name, manufacturer, etc. Search the database by: test system name … to information about the CLIA parent document, such as: 510(k) summary; or PMA summary of safety and effectiveness. … The Special 510(k) Program Sep 9, 2024 · Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links. A 510(k) is a premarketing 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 marketed device that is not subject to premarket approval (PMA). Mar 16, 2021 · Search the database of releasable 510 (k)s for medical devices submitted to FDA by manufacturers. Aug 31, 2024 · The search will return up to 500 results for MDRs received by FDA in the selected year. Dental Composite Resin Devices - Premarket Notification (510(k)) Submissions Draft Guidance for Industry and Food and Drug Administration Staff July 2024 Sep 9, 2024 · Date Received: 08/18/2023: Decision Date: 11/17/2023: Decision: Substantially Equivalent (SESE) Regulation Medical Specialty: Cardiovascular Sep 2, 2024 · Date Received: 01/17/2023: Decision Date: 01/19/2024: Decision: Substantially Equivalent (SESE) Regulation Medical Specialty: Gastroenterology/Urology Sep 9, 2024 · Device Classification Name: Tubes, Vials, Systems, Serum Separators, Blood Collection: 510(k) Number: K230391: Device Name: BD MiniDraw™ Capillary Blood Collection System with BD MiniDraw™ SST™ Capillary Blood Collection Tube Sep 9, 2024 · Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links. 510(k) Number: K233114: Device Name: LED silicone mask (Model: LP 10903 New Hampshire Avenue Silver Spring, MD 20993 Ph. Table of Contents. In order to use the 510(k) pre-market notification process, a new device requires that an existing predicate device that also used the 510(k) process be identified. Apr 16, 2024 · This database allows users to search for existing submissions using criteria such as the 510(k) number, applicant, device name, or FDA product code. 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. If you choose to submit a 510(k) Statement, the regulation requires the specific Mar 23, 2023 · A thorough search of the 510(k) database is essential in helping to identify predicate devices that are suitable for comparison. A longer introduction to Premarket Notification 510(k) is also available. Steps to Access 510(k) Data. 510(k) Devices Cleared in 2021(Archived) Search the 510(k) Premarket Notification 1 day ago · 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. The FDA offers many helpful, additional resources such as the following: Premarket Notification 510(k) searchable database; CFR search engine. 1-888-INFO-FDA (1-888-463-6332) Contact FDA Jul 12, 2024 · GUIDANCE DOCUMENT. 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. The 510 (k) premarket notification process is a critical step in ensuring that a new medical device can be legally marketed in the United States. Applicant Name. 510(k) (premarket notification) to FDA is required at least 90 days before marketing unless the device is Sep 9, 2024 · Search Database: Help Download Files: Applicant Product Code Device 510(k)s; De Novo; Medical Device Reports (MAUDE) CDRH Export Certificate Validation (CECV) Search the Releasable 510(k) Database Downloadable 510(k) Files FDA Continues to Take Steps to Strengthen the Premarket Notification [510(k)] Program - Program Updates Oct 3, 2022 · The FD&C Act and the 510(k) regulation (21 CFR 807) do not specify who must submit a 510(k). 510(K) Number. Nov 24, 2023 · The USFDA 510(k) Database serves as a centralized repository for all USFDA 510(k) submissions, clearances, and approvals under the 510(k) process. FDA will place the summary on the Internet 30 days following the substantial equivalent decision. Find 510 (k) number, applicant, device name or FDA product code and summaries of safety and effectiveness information. market, require a 510(k Search the 510(k) Database Premarket Approval (PMA) is the most stringent type of device marketing application required by FDA. You can read the FDA 510(k) acceptance criteria hereut provides great information, and you should study it carefully before starting your 510(k). Users can search for previously cleared 510(k) submissions from this database using search criteria such as but not limited to: 510(k) Number. Sep 9, 2024 · Date Received: 01/17/2023: Decision Date: 08/04/2023: Decision: Substantially Equivalent (SESE) Regulation Medical Specialty: Dental Sep 9, 2024 · Date Received: 08/22/2023: Decision Date: 09/06/2024: Decision: Substantially Equivalent (SESE) Regulation Medical Specialty: Gastroenterology/Urology Sep 9, 2024 · 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 response to a 510(k) submission. The database facilitates transparency, allowing users to access crucial details about medical devices, their indications, technological specifications, safety profiles, and more. U. Navigate to the FDA's website dedicated to 510(k) clearance; locate the searchable 510(k) database prominently featured therein. Sep 9, 2024 · Device Classification Name: Monitor, Cardiac (Incl. 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 1 day ago · This database includes: a list of all medical devices with their associated classifications, product codes, FDA premarket review organizations, and other regulatory information. All data on 510k. Food & Drug Administration 510(k) Number: K230620: Device Name: Mar 30, 2001 · The FDA maintains several publicly accessible databases that may … of neurological devices including: Product classification 510k Premarket Notification database Premarket Approvals (PMA Sep 9, 2024 · Date Received: 07/16/2021: Decision Date: 09/16/2022: Decision: Substantially Equivalent (SESE) Regulation Medical Specialty: General Hospital Oct 16, 2023 · Now FDA uses a 50+ point review checklist before accepting any 510(k) for substantive review. Decision Date. 510(k) Number: K233417: Device Name: AllTest Fentanyl Urine Test Date Received: 02/21/2023: Decision Date: 06/22/2023: Decision: Substantially Equivalent (SESE) Regulation Medical Specialty: Neurology Sep 9, 2024 · Device Classification Name: Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents: 510(k) Number: K233100. The file layout describes the data fields. When writing a 510(k) submission, medical device companies should focus on providing detailed information about the device's intended use, technological characteristics, and explain any differences between the new Sep 2, 2024 · Date Received: 12/04/2020: Decision Date: 10/18/2022: Decision: Substantially Equivalent (SESE) Regulation Medical Specialty: Clinical Chemistry What You Need to Know about FDA 510(k) Database. human medical devices. It also contains administrative and tracking information about the applications and receipt and decision dates. 510(k) Number: K230100: Device Name: SCIZER (SC1-M410) Applicant: Sep 9, 2024 · Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links. Food & Drug Administration 510(k) Number: K222780: Device Name: Sep 9, 2024 · Date Received: 12/12/2022: Decision Date: 12/15/2023: Decision: Substantially Equivalent (SESE) Regulation Medical Specialty: Cardiovascular Sep 9, 2024 · Date Received: 02/06/2020: Decision Date: 03/06/2020: Decision: Substantially Equivalent (SESE) Regulation Medical Specialty: General & Plastic Surgery Pre-market Notifications - 510(k) The 510(k) database includes all released 510(k) submissions and can be searched by 510(k) number, type, product code, device name, and more. - - Sep 7, 2024 · Explore the FDA 510 (k) database for medical device compliance. Device name. Steps to performing an efficient 510(k) database search: The openFDA Device 510(k) Clearances API contains details about specific products and the original sponsors of premarket notification applications. Jan 31, 2022 · The FDA 510 k database search is made easy for manufacturers with the user-friendly interface of its official website. mknazgzhpzoiserhjowmkelpgalixlwjppwnwedtrswhpmeixrvwgvetgghsf
