FDA 510(k) Medical Device Database

A 510(k) is a premarket submission to the FDA demonstrating that a medical device is substantially equivalent to a legally marketed predicate device. Required for most Class I and Class II devices sold in the U.S.

Regulatory affairs professionals, medical device manufacturers, healthcare procurement teams and researchers use this database to verify device clearances, find predicate devices and track competitor submissions.

The FDA publishes updated 510(k) records on the 5th of each month. This database syncs automatically within 24 hours of each FDA release.

Cleared (SESE) means the FDA determined the device is substantially equivalent and may be marketed in the U.S. Not cleared (DENG) means the FDA found the device is not substantially equivalent to any predicate.

Use the search bar at the top of this page. You can search by device name, manufacturer name, or K-number (e.g. K243854). You can also browse by medical specialty or filter by decision, year, or product code. Results link directly to the full device record and the official FDA submission.

No. 510(k) clearance means the FDA determined a device is substantially equivalent to a legally marketed predicate device. It is used for most Class I and Class II devices. FDA approval (PMA - Premarket Approval) is a separate, more rigorous process required for high-risk Class III devices, based on clinical trial evidence of safety and effectiveness. It is legally incorrect to describe a 510(k)-cleared device as "FDA approved."

Yes, partially. The FDA publishes the decision, device name, applicant, product code, and a summary of safety and effectiveness for each 510(k) within 30 days of the decision. Detailed technical and proprietary information is withheld. Full submissions can be requested via FOIA, though they are often heavily redacted. All records in this database are sourced from the FDA 510(k) public files, which are in the public domain.

The FDA recognizes three types of 510(k) submission. A Traditional 510(k) is the standard path, requiring full substantial equivalence documentation. A Special 510(k) is a streamlined path for modifications to a manufacturer's own legally marketed device. An Abbreviated 510(k) relies on FDA-recognized standards or special controls to demonstrate substantial equivalence, simplifying the submission.

No, a 510(k) clearance does not have an expiration date. However, if a manufacturer makes a significant change to a cleared device - in design, materials, intended use, or manufacturing - a new 510(k) submission may be required before marketing the modified device. The FDA provides guidance on when changes require a new submission.

Beyond the core FDA clearance data, individual device records are progressively enriched with information from official public sources. This includes the regulatory consultant who managed the 510(k) submission - a signal useful for competitive intelligence - as well as flags for third-party review, combination product status, and Predetermined Change Control Plan (PCCP) authorization, relevant for AI and software-based devices. When a 510(k) references a registered clinical trial, the device record links to the full study data from ClinicalTrials.gov, including design, enrollment, outcomes and publication status. Not all records have been enriched - coverage expands over time.

No. 510k Database is an independent, search tool built on top of the FDA's publicly available 510(k) data files. It is not affiliated with or endorsed by the U.S. Food and Drug Administration. The official FDA 510(k) search tool is available at accessdata.fda.gov. This database uses the same underlying public data but offers enhanced search, manufacturer profiles, product code browsing, and monthly clearance analysis not available on the FDA's own interface. Learn more on the About page.

Search by device type, product code, or manufacturer to find cleared devices that could serve as predicates. Use the advanced search to filter by FDA review panel, decision year, or product code and narrow results to your device category. Each device record links directly to the full submission on accessdata.fda.gov where predicate device information is documented. You can also browse by product code category to find all cleared devices within a specific classification, or explore devices by medical specialty.

FDA 510(k) review time varies by device category, submission quality, and review pathway. While the FDA target review timeline is 90 days, real-world clearance timelines are often longer. Based on historical FDA submission records analyzed in this database, median review durations vary significantly across specialty panels and device types.

A predicate device is a legally marketed medical device used to demonstrate substantial equivalence during an FDA 510(k) submission. Manufacturers compare their new device to one or more predicates to show similar intended use, technology, and safety characteristics.