2s FDA Medical Device 510(k) Clearance Lookup

API ↗

2s FDA Medical Device 510(k) Clearance Lookup is a paid API for AI agents from 2s.io, paid per call via x402, $0.0018/call, status unknown (last checked 2026-09-14).

Searches FDA 510(k) clearance records by device name, applicant/manufacturer, or product code, returning official clearance details including K-number, decision date, and advisory committee.

How this service works

FDA 510(k) premarket clearances — the record of medical devices cleared for US marketing by demonstrating substantial equivalence to a predicate device. Search by device name, applicant (manufacturer), or FDA product code, and get back each clearance with its K-number, device name, applicant, decision date and decision description, clearance type (traditional/special/abbreviated), product code, advisory committee, and date received — newest decision first. Free, public-domain US government data. Authoritative regulatory-status data for medical-device diligence; point-in-time public records, not regulatory advice.

Output

Returns a list of FDA 510(k) clearance records matching the query, each with K-number, applicant/manufacturer name, device name, FDA product code, date received, decision date, clearance type (e.g. Traditional), advisory committee (e.g. Cardiovascular), decision description (e.g. Substantially Equivalent), and state/country. Also includes total count of matching records and the data source attribution.