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510 k searchable database

  • 510 k searchable database. ” Mar 22, 2024 · Title21 Part. Section 4. Regulated Product(s) Medical Devices; 510(k) Clearances 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. Food and Drug Administration (FDA) 510(k) clearance and the commercial launch of the Sensinel™ Cardiopulmonary Management (CPM) System. Summaries of safety and effectiveness information is available via the web interface for more recent records. This May 29, 2024 · 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. Food & Drug Administration 510(k) Number: K222780: Device Name: Aug 26, 2024 · Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links. Instead, they specify which actions, such as introducing a device to the U. Device name. 1-888-INFO-FDA (1-888-463-6332) Contact FDA Aug 19, 2024 · 10903 New Hampshire Avenue Silver Spring, MD 20993 Ph. 0 – Truthful and Accuracy Statement. The Special 510(k) and Abbreviated 510(k 3 days ago · Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links. It also contains administrative and tracking information about the applications and receipt and decision dates. Section 8. Section (e. Find device name, applicant, 510 (K) number, decision date and more information for each submission. 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 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. 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. Content current as of: 02/07/2024. On this page: 510(k) Exemptions; Cures Act Exemptions; Date Received: 02/21/2023: Decision Date: 06/22/2023: Decision: Substantially Equivalent (SESE) Regulation Medical Specialty: Neurology Aug 26, 2024 · Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links. Learn about 510 (k) requirements, exemptions, and substantially equivalent devices. 1-888-INFO-FDA (1-888-463-6332) Contact FDA Aug 26, 2024 · Date Received: 01/17/2023: Decision Date: 08/04/2023: Decision: Substantially Equivalent (SESE) Regulation Medical Specialty: Dental Mar 5, 2024 · WILMINGTON, Mass. 510(k) Statement. 510(k) Number: K231470: Device Name: Lunit INSIGHT DBT: Applicant: Aug 26, 2024 · 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. S. Search the FDA database of 510 (k) submissions for medical devices that are substantially equivalent to legally marketed devices. Search by panel, 510 (k) number, product code or device name and see summary or statement, decision, classification and more. market, require a 510(k 3 days ago · 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 The openFDA Device 510(k) Clearances API contains details about specific products and the original sponsors of premarket notification applications. Group 3 – Templated Sections. Food & Drug Administration 510(k) Number: K231966: Device Name: 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. The U. , then the owner/operator should also provide the FDA premarket submission number (510(k), De Novo, PMA, PDP, HDE). Dental Composite Resin Devices - Premarket Notification (510(k)) Submissions Draft Guidance for Industry and Food and Drug Administration Staff July 2024 Aug 26, 2024 · Date Received: 08/18/2023: Decision Date: 11/17/2023: Decision: Substantially Equivalent (SESE) Regulation Medical Specialty: Cardiovascular The FDA maintains several publicly accessible databases that may … of neurological devices including: Product classification 510k Premarket Notification database Premarket Approvals (PMA 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. … The Special 510(k) Program Aug 26, 2024 · Date Received: 05/08/2023: Decision Date: 02/02/2024: Decision: Substantially Equivalent (SESE) 510k Review Panel: General & Plastic Surgery Aug 26, 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. 3 days ago · This database includes: a list of all medical devices with their associated classifications, product codes, FDA premarket review organizations, and other regulatory information. Mar 23, 2023 · A thorough search of the 510(k) database is essential in helping to identify predicate devices that are suitable for comparison. The advanced search will return up to 500 results for MDRs received over the selected timeframe. The intent of this guidance is to identify The foreign manufacturer may submit a 510(k) directly to FDA. Aug 26, 2024 · Date Received: 09/22/2022: Decision Date: 12/30/2022: Decision: Substantially Equivalent (SESE) Regulation Medical Specialty: Dental Aug 26, 2024 · Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links. 1, Critical Care Suite. 0 – 510(k) Summary. The FDA's 510(k) program provides clearance for 99% of U. 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. 1385) Full Text Search : CFR Title 21 - Food and Drugs: Parts 1 to 1499 Aug 26, 2024 · Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links. The file layout describes the data fields. For additional information, please visit the FDA's Premarket Notification 510(k) page. Typically, they will add new devices around the 5th of each month for devices cleared in the prior month. Section 7. 510(k) Number: K233114: Device Name: LED silicone mask (Model: LP Nov 24, 2021 · Databases. 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. 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 convenience, a foreign manufacturer may receive assistance from a U. Jan 31, 2022 · The FDA 510 k database search is made easy for manufacturers with the user-friendly interface of its official website. The compact wearable device is a non-invasive, remote management system that captures cardiopulmonary Nov 9, 2016 · To access this database, click on this link: Redacted FOIA 510k Database. Aug 26, 2024 · Date Received: 09/18/2023: Decision Date: 11/01/2023: Decision: Substantially Equivalent (SESE) Regulation Medical Specialty: Gastroenterology/Urology 3 days ago · Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links. over a specific timeframe. Mar 16, 2021 · This database of releasable 510(k)s can be searched by 510(k) number, applicant, device name or FDA product code. Product Code. 510(k) Number: K230100: Device Name: SCIZER (SC1-M410) Applicant: Oct 2, 2023 · A vast majority of medical devices in the United States are cleared by the US FDA through the 510(k) regulatory pathway. Thus, the premarket notification is colloquially known as a 510(k) submission. , 862. S Aug 19, 2024 · Device Classification Name: Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents: 510(k) Number: K230956 Nov 29, 2023 · If a device requires a premarket submission before being marketed in the U. g. 510(k) Number: K233417: Device Name: AllTest Fentanyl Urine Test Jul 31, 2024 · 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. 1-888-INFO-FDA (1-888-463-6332) Contact FDA Aug 26, 2024 · Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links. 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 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. To limit your search to only 510k submissions that are available as a redacted full 510k, just click on the box for “Redacted FOIA 510k. Search the 510(k) Database Premarket Approval (PMA) is the most stringent type of device marketing application required by FDA. , March 5, 2024 /PRNewswire/ -- Analog Devices, Inc. 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. Food & Drug Administration 510(k) Number: K231237: Device Name: Date Received: 03/07/2022: Decision Date: 12/08/2022: Decision: Substantially Equivalent (SESE) Regulation Medical Specialty: Gastroenterology/Urology Search the database by: test system name; analyte name; complexity; specialty; date of categorization; Many of the records contain links to information about the CLIA parent document, such as: 510 Jul 10, 2023 · 510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD June 2023 DEVICE: Tisuthes e-PTFE Surgical Patch Shanghai Suokang Medical Implants 510(k) NO: K201153 10903 New Hampshire Avenue Silver Spring, MD 20993 Ph. 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. 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. 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). The MAUDE database: Aug 26, 2024 · Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links. All data on 510k. 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. 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 Federal Aug 26, 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 Aug 26, 2024 · Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links. Once accepted, a 510(k) proceeds to the Substantive Review. entity and may use a contact person residing in the U. 510(k) Number: K234027: Device Name: embecta Insulin Delivery System: Aug 26, 2024 · Date Received: 04/27/2023: Decision Date: 03/30/2024: Decision: Substantially Equivalent (SESE) Regulation Medical Specialty: Neurology Section 3. Reports older than ten years are provided on the FDA's MDR Data Files webpage. SCoV-2 Ag Detect Rapid Test. 0 – Indications for Use Statement. (Nasdaq: ADI) today announced U. U. 0 – Class III Summary and Certification. 510(k) (premarket notification) to FDA is required at 3 days ago · Date Received: 02/06/2020: Decision Date: 03/06/2020: Decision: Substantially Equivalent (SESE) Regulation Medical Specialty: General & Plastic Surgery Aug 26, 2024 · Date Received: 04/18/2024: Decision Date: 07/25/2024: Decision: Substantially Equivalent (SESE) Regulation Medical Specialty: Dental Aug 26, 2024 · Date Received: 07/18/2022: Decision Date: 03/17/2023: Decision: Substantially Equivalent (SESE) Regulation Medical Specialty: Neurology Oct 4, 2022 · In 2019, the FDA split The New 510(k) Paradigm into two distinct guidance documents: The Special 510(k) Program and The Abbreviated 510(k) Program. human medical devices. … The Special 510(k) Program Aug 26, 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 Aug 26, 2024 · Date Received: 12/12/2022: Decision Date: 12/15/2023: Decision: Substantially Equivalent (SESE) Regulation Medical Specialty: Cardiovascular FDA will place the summary on the Internet 30 days following the substantial equivalent decision. Home; Food; Drugs; Medical Devices; Radiation-Emitting Products; 510(k) Number: K211869: Device Name: OGM 1 Polymethylmethacrylate (PMMA) bone cement Aug 26, 2024 · Date Received: 07/13/2023: Decision Date: 12/08/2023: Decision: Substantially Equivalent (SESE) Regulation Medical Specialty: Dental Aug 26, 2024 · Date Received: 03/23/2023: Decision Date: 03/15/2024: Decision: Substantially Equivalent (SESE) Regulation Medical Specialty: Hematology Aug 7, 2023 · 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 To determine whether a device is exempt from 510(k) or GMP requirements, search the FDA’s Product Classification database. 510(k) Devices Cleared in 2021(Archived) Search the 510(k) Premarket Notification Aug 26, 2024 · 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. Find information on medical devices cleared by FDA through the 510 (k) process. Users can search for previously cleared 510(k) submissions from this database using search criteria such as but not limited to: 510(k) Number. Applicant Name. Steps to Access 510(k) Data. 0 – 510(k) Cover Letter. 307 Westlake Ave N, Suite 300. Only FDA generated product codes will work with the 510(k) and other FDA databases. Advanced search allows a user to search on specific fields such as device brand name, manufacturer, etc. The database facilitates transparency, allowing users to access crucial details about medical devices, their indications, technological specifications, safety profiles, and more. Aug 26, 2024 · Date Received: 12/04/2020: Decision Date: 10/18/2022: Decision: Substantially Equivalent (SESE) Regulation Medical Specialty: Clinical Chemistry Nov 6, 2023 · This page lists all medical devices cleared through the CDRH Premarket Notification process [510(K)] in 2021. Aug 26, 2024 · Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings 22. Find information on product code, center, applicant name, decision date and more. Find information and downloads about 510 (k) clearances, a premarket submission to FDA for medical devices. Aug 26, 2024 · Date Received: 01/17/2023: Decision Date: 01/19/2024: Decision: Substantially Equivalent (SESE) Regulation Medical Specialty: Gastroenterology/Urology Aug 26, 2024 · Device Classification Name: Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents: 510(k) Number: K233100 May 2, 2022 · Releasable 510(k)s: Searchable and ZIP: Releasable PMAs: Searchable and ZIP: 510(k) Summaries: Searchable: Product Code Data: Searchable and ZIP: Adverse Events MDR Data; MAUDE Data; Some Search FDA . Search the FDA database for 510 (K) premarket notification submissions of medical devices. fyi is derived from the official FDA 510(k) database What You Need to Know about FDA 510(k) Database. Device Name. Section 5. Aug 26, 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. 510 (k) Number. Search the 510 (k) database by year or download zipped files, or browse for clearances by year. Feb 7, 2024 · December 2023 510(k) Clearances (database) Search the 510(k) Premarket Notification database. Aug 26, 2024 · 10903 New Hampshire Avenue Silver Spring, MD 20993 Ph. 510(k) Number: K163636: Device Name: ePlex Respiratory Pathogen Panel: Aug 26, 2024 · Date Received: 09/01/2023: Decision Date: 09/08/2023: Decision: Substantially Equivalent (SESE) Regulation Medical Specialty: Cardiovascular Jun 6, 2023 · Use CDRH’s Customer Collaboration Portal secure website to send eSTAR and eCopy premarket submissions and track progress of 510(k) submissions online. Oct 3, 2022 · The FD&C Act and the 510(k) regulation (21 CFR 807) do not specify who must submit a 510(k). Date Received: 09/01/2004: Decision Date: 10/25/2004: Decision: Substantially Equivalent (SESE) Regulation Medical Specialty: Ear Nose & Throat 3 days ago · This database includes: a list of all medical devices with their associated classifications, product codes, FDA Premarket Review organizations, and other regulatory information. Section 6. Applicant. CDRH maintains searchable databases on its website containing 510(k) and PMA information. Steps to performing an efficient 510(k) database search: A longer introduction to Premarket Notification 510(k) is also available. InBios International, Inc. Cardiotachometer & Rate Alarm) 510(k) Number: K212143: Device Name: Neteera 130H/131H Vital Sign Monitoring Sensor Aug 26, 2024 · Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links. A PMA is an application submitted to FDA to request approval to market. 0 – Financial Certification or Disclosure Statement Nov 1, 2022 · The 510(k) database, in contrast, is data entered by FDA review staff based on what a manufacturer provides. 5 days ago · The search will return up to 500 results for MDRs received by FDA in the selected year. If you choose to submit a 510(k) Statement, the regulation requires the specific 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. Food & Drug Administration 510(k) Number: K230620: Device Name: FDA developed this document to provide guidance to industry and FDA staff about current review practices for premarket notification (510(k)) submissions. 510(k)s for similar device types are usually linked in the 510(k) database by the same product code. 1-888-INFO-FDA (1-888-463-6332) Contact FDA Aug 26, 2024 · Device Classification Name: Monitor, Cardiac (Incl. While not the only submission method to the US FDA for medical devices, the 510(k) pathway is Aug 26, 2024 · Device Classification Name: Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents: 510(k) Number: K220963 Aug 26, 2024 · 10903 New Hampshire Avenue Silver Spring, MD 20993 Ph. Navigate to the FDA's website dedicated to 510(k) clearance; locate the searchable 510(k) database prominently featured therein. The FDA offers many helpful, additional resources such as the following: Premarket Notification 510(k) searchable database; CFR search engine. Aug 26, 2024 · Device Classification Name: Pump, Infusion: 510(k) Number: K231918: Device Name: Freedom60 Infusion Pump; High-Flo Subcutaneous Needle Sets; Precision Flow Rate Tubing; High-Flo Super26 Subcutaneous Needle Sets; Freedom60 Pre-Filled Syringe Adapter Aug 26, 2024 · Date Received: 11/05/2021: Decision Date: 07/25/2023: Decision: Substantially Equivalent (SESE) Regulation Medical Specialty: Clinical Chemistry Aug 26, 2024 · Device Classification Name: Radiological Computer Assisted Detection/Diagnosis Software For Fracture: 510(k) Number: K223491: Device Name: Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2. 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. K233358. Content current as of: 11/06/2023 Sep 6, 2023 · The principles of safety and effectiveness underlie the 510(k) clearance process for medical devices, ensuring patients are protected as best as possible from risks while allowing patients to Jul 12, 2024 · GUIDANCE DOCUMENT. qmbwksm ahdkl tgdokt nqwnv zfh reytwmj hppoj emu kxwyoi jcqq