FDA 510(k) database search
Search every 510(k) clearance FDA has issued since 1976, by device name, applicant, K number or product code. Results come straight from FDA's openFDA API and each one links back to FDA's own record. Free, no signup, nothing stored.
Finding a predicate device
A 510(k) submission argues that your device is substantially equivalent to one already legally marketed. Choosing that predicate well is most of the work, because the comparison sets the evidence you have to produce.
The fastest route is the product code. FDA assigns each device a three-letter code grouping devices with the same intended use and technology, so every clearance under one code is a candidate. Search by device name, then click the product code on any result to list its siblings.
What this tool cannot tell you is whether a predicate is a good one. That depends on intended use wording, technological characteristics, whether the predicate has since been recalled, and how FDA has treated comparable submissions. Those live in the clearance summaries and decision letters rather than in this index.
Frequently asked questions
- What is the FDA 510(k) database?
- It is FDA's public record of premarket notification submissions and their outcomes, covering clearances from 1976 onward. Each record shows the K number, device name, applicant, decision and date, and the product code assigned to the device.
- What is a predicate device?
- A legally marketed device you compare your own to in order to establish substantial equivalence. In practice a predicate is usually found among earlier clearances sharing the same product code and intended use.
- How do I find a predicate device?
- Search by device name to find comparable clearances, then use the product code on any result to list every other device cleared under that code. Narrowing by product code is the fastest route to a shortlist of candidates.
- What is a product code?
- A three-letter code FDA assigns to group devices with the same intended use and technology, such as FRN for infusion pumps. It is the most reliable field for finding comparable clearances.
- Is this data official?
- The results come directly from FDA's openFDA API, and every K number links to FDA's own detail page so you can verify it at source. FDA updates the dataset periodically, so very recent decisions may not appear immediately.
- Does searching cost anything or require an account?
- No. The search runs in your browser against FDA's public API. Nothing you type is sent to Arca or stored.
Related reading
- What is GxP? — including how 21 CFR 820 became the QMSR in February 2026
- Complete Response Letters — what happens when a submission is not approved
- Regulatory glossary
Building the submission, not just finding the predicate
Arca reads clearance summaries, decision letters and your own design history file together, and drafts the substantial equivalence comparison with every claim cited back to its source.