openfda_devices.clearances_510k
mock data$0.002 / callFDA 510(k) Premarket Clearances
Search FDA 510(k) premarket clearance submissions — 175,000+ cleared medical devices. Returns k_number, device name, applicant, decision (SESE=cleared), decision date, product code, advisory committee specialty, and clearance type (Traditional/Special/Abbreviated). Filter by device name, k-number, applicant, or product code. A 510(k) clearance means FDA determined the device is substantially equivalent to a legally marketed predicate device. Useful for market research, competitive analysis, and regulatory pathway planning. Source: FDA CDRH 510(k) database, US public domain.
Input schema
Number of records to skip for pagination (default 0).
Number of records to return (1–99, default 10).
OpenFDA search expression using Lucene syntax. Single field: device_name:"pacemaker" or recall_status:"Ongoing". Combined: device_name:"insulin pump"+AND+recall_status:"Ongoing". Omit to return recent records sorted by date.
Call via REST
curl -X POST https://unifyapi.pro/api/call/openfda_devices.clearances_510k \
-H "Authorization: Bearer uak_live_..." \
-H "Content-Type: application/json" \
-d '{"skip":0,"limit":0,"search":"<search>"}'