How to Search the FDA 510(k) Database

510k Database is a free, independent FDA 510(k) searchable database covering 174,000+ cleared medical devices from May 1976 to the present, updated monthly from official FDA data. It goes beyond the official FDA interface with manufacturer profiles, review time benchmarks, and regulatory consultant data.

510k Database lets you search and explore 174,000+ FDA 510(k) cleared medical devices and access regulatory information quickly and efficiently. The database covers clearances from May 1976 to the present, updated monthly from official FDA data. You can Search by K-number, device name, manufacturer name, or product code.

Search by 510(k) Number (K-number)

The fastest and most precise way to find a specific clearance record is to search by its FDA 510(k) number - also called K-number. Every cleared device has a unique K-number assigned by the FDA, in the format K followed by six digits.

Example: search K253986 to open the full device record - including classification, manufacturer details, panel assignment and clearance date.

K-number searches return an exact match and open directly to the full device record, which includes the official FDA decision, product code, review panel, days to clearance, and links to the FDA summary document. If you already know the K-number of a device you are looking for, this is the most reliable search method.

Search the FDA 510(k) database

Search by Device Name

Search by generic device name to find all cleared devices of a given type. Use broad generic terms rather than brand names - the FDA records device names using standard medical terminology.

Example: search catheter to see all 510(k)-cleared catheter devices, filterable by specialty panel, product code and decision year.

Device name searches are particularly useful for finding predicate devices - cleared devices that can be cited in a new 510(k) submission to demonstrate substantial equivalence. Filter results by product code or panel to narrow down to your specific device category. If a search returns too many results, use the Advisory Committee Panel filter (Orthopedic, Cardiovascular, Radiology, etc.) to focus on your medical specialty.

FDA 510(k) database search

Search by Manufacturer

Search by manufacturer name to see all 510(k) clearances submitted by a specific company. Each manufacturer has a dedicated profile page showing their full clearance history, device categories, and regulatory activity in one place.

Example: search Intuitive Surgical to view all their cleared devices and open the full company profile - including clearance history, active product codes, and panel distribution.

Manufacturer profiles are useful for competitive intelligence - understanding which devices a competitor has cleared, which panels they work with, and how their submission activity has evolved over time. Each profile also shows the regulatory consultants who have managed submissions on behalf of the company.

Browse manufacturer database

Search by Product Code

Product codes are 3-letter FDA classification identifiers that group devices by type. Searching by product code returns all 510(k) clearances within a specific device category - the most focused way to find predicate devices and benchmark review times for your exact device type.

Example: product code QIH covers AI-enabled software as a medical device (SaMD). Searching by QIH shows all cleared AI imaging devices, their review times, and the consultants who managed the submissions.

You can browse all 339 product code categories directly from the search interface to identify the correct code for your device before searching. Each category page shows total cleared devices, average review time, and top manufacturers.

Browse product codes

Search Tips

  • Use generic terms rather than brand names - the FDA uses standard medical terminology in device names.
  • If a search returns too many results, filter by specialty panel (Orthopedic, Cardiovascular, Radiology, etc.) to narrow to your device category.
  • Each device record links directly to the official FDA summary document - useful for reading the predicate device rationale and substantial equivalence argument.
  • The regulatory consultant field shows which firm managed the submission - useful for competitive intelligence and consultant benchmarking.
  • Use the review time data on each panel page to benchmark how long your submission is likely to take before filing.
  • Search results include denied submissions (DENG) as well as cleared ones - useful for understanding which device types face higher rejection rates.

510k Database is not affiliated with or endorsed by the FDA. Data is sourced from the FDA 510(k) public files and updated monthly. Always verify submission requirements directly at accessdata.fda.gov.