Fda 510 k database. Find summaries of safety and effectiveness information for more recent records. Oct 13, 2025 · 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. Search the PMN database here. Oct 13, 2025 · 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. We would like to show you a description here but the site won’t allow us. As of 2024, remaining Oct 13, 2025 · This database includes: a list of all medical devices with their associated classifications, product codes, FDA Premarket Review organizations, and other regulatory information. The latest PMN approved devices are listed below. The database facilitates transparency, allowing users to access crucial details about medical devices, their indications, technological specifications, safety profiles, and more. FDA 510 (k) PMA Database of Premarket Approvals PMA is the most stringent type of device marketing application required by FDA. Search by panel, 510 (k) number, product code or device name and see summary or statement, decision, classification and more. FDA 510 (k) PMN Database of Premarket Notifications PMN requirements apply to Class III devices, the most stringent regulatory category for medical devices. Search the 510 (k) Database Premarket Approval (PMA) is the most stringent type of device marketing application required by FDA. … The Special 510 (k) Program The Abbreviated 510 (k) Program uses guidance documents, special controls, … standards to facilitate FDA's premarket review of 510 (k) submissions. Feb 2, 2018 · You can search the releasable 510 (k) database by Panel, 510 (k) number, Product code or Device name. CDRH Databases: a listing of databases for such topics as advisory committees, regulations, good practices, medical devices, Premarket Approval (PMA) and Notification (510 (k)), product codes 510 (k) Clearances 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). Find information on medical devices cleared by FDA through the 510 (k) process. Device 510 (k) Overview A 510 (k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (21 CFR 807. The applicant must receive FDA approval of its PMA application prior to marketing the device. The alternative approach described in … May 28, 2025 · The FDA has added six new subcategories to make it easier for users of the 510(k) Premarket Notification Database to search for cleared medical devices. In this process Oct 13, 2025 · 510 (k) Premarket NotificationFDA Home Medical Devices Databases Aug 22, 2024 · premarket notifications, devices, device advice, substantial equivalence, when to submit a 510 (k), requirements for submission, third party review. Oct 13, 2025 · 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 Sep 11, 2025 · Explore the importance of the 510 (k) FDA database for ensuring medical device safety and compliance through effective QA audits. This summary is not merely an overview; it's an essential comparison tool that delineates the similarities and differences between the new medical device and a previously cleared predicate device. Check the status of an FDA 510 (k) Application by browsing to it by company name. A PMA is an application submitted to FDA to request approval to market. Find all the FDA 510 (k) Applications submitted by any company contact. A crucial aspect of the FDA 510 (k) submission process is the 510 (k) summary, which is pivotal in the FDA's public database. A search query will produce information from the database in the following format: Oct 13, 2025 · 510 (k) Final Decisions FDA Home Information on Releasable 510 (k)s Database Updated 10/13/2025 You can download any of the following zipped files, each of which contains information about the releasable 510(k)s for the time frame indicated. Research competitors that have submitted FDA 510 (k) Applications for the same devices as your company. PMA approval is based on a determination by FDA that the PMA contains sufficient valid scientific evidence to assure that the device is safe and effective for its intended Oct 13, 2025 · 510 (k) Premarket NotificationFDA Home Medical Devices Databases Oct 13, 2025 · This database includes: a list of all medical devices with their associated classifications, product codes, FDA Premarket Review organizations, and other regulatory information. 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. Master the 510 k database with this step-by-step navigation guide for FDA compliance. Jul 11, 2025 · Search the database of releasable 510 (k)s submitted by medical device manufacturers to FDA. 92 (a) (3)) that is not subject to PMA. Find out how to notify FDA of your intent to market a medical device and browse the 510 (k) Premarket Notification database. Jun 3, 2025 · Learn how to navigate the FDA 510(k) database, avoid common mistakes, and use it effectively in regulatory and product research. Learn about the 510 (k) clearance process, safety and performance based pathway, and other resources. As of 2024, remaining 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. The openFDA Device 510 (k) Clearances API provides a valuable resource for tracking applications and understanding the regulatory landscape. Familiarity with the FDA 510 (k) clearance database is imperative for effectively navigating this regulatory landscape, allowing manufacturers to find pertinent information and ensure compliance with the latest regulatory standards. The alternative approach described in … Oct 13, 2025 · 510 (k) Registration & Listing Adverse Events PMA Recalls Products CLIA CFR Title 21 Radiation-Emitting Products X-Ray Assembler Medsun Standards The Abbreviated 510 (k) Program uses guidance documents, special controls, … standards to facilitate FDA's premarket review of 510 (k) submissions. A Premarket Notification [510(k)] is a premarket submission that proves substantial equivalence to a predicate device and is not subject to Premarket Approval. Quickly find FDA 510 (k) Applications by Common Device Name. 1rgd8 sww 2ii qf9ys fa1oz1 ej3 hs3l aml bk6ywtlw w6ox