Search 510(k) clearances, trace predicate device chains, and map competitive landscapes — all from real FDA data, indexed and queryable via API.
Query by device name, applicant/manufacturer, K-number, or product code. Results come directly from indexed FDA data.
Enter a K-number to walk its predicate chain up to 10 levels deep. See how devices build on each other through FDA's substantial equivalence pathway.
ClearanceIQ replaces weeks of manual FDA database research with instant, structured intelligence.
Identify the optimal predicate device for your 510(k) submission. Map clearance pathways competitors have used for similar devices.
Track which companies are clearing devices in your product category. Monitor applicant portfolios and product code activity.
Audit a target's 510(k) portfolio before acquisition. Assess regulatory risk and IP positioning through predicate chain analysis.
Five endpoints covering clearance search, predicate chain traversal, and applicant profiling.
/api/clearance/:knumber
/api/search?q=&device=&applicant=&product_code=
/api/predicates/:knumber
/api/applicant/:name
# Trace predicate chain for a device curl "http://localhost:3003/api/predicates/K203456" # Response { "k_number": "K203456", "chain_depth": 3, "chain": [ { "k_number": "K203456", "device_name": "Hip System", "applicant": "Stryker" }, { "k_number": "K190123", "depth": 1, "parent": "K203456" }, { "k_number": "K170890", "depth": 2, "parent": "K190123" } ] }
Get your API key and start querying FDA 510(k) data in minutes.