openfda_device_clearances
Search FDA 510(k) medical device clearances by applicant, device name, product code, clearance type, K-number, or state. Retrieve clearance details, decision dates, and manufacturer information.
Instructions
Search openFDA 510(k) DEVICE CLEARANCES — FDA premarket-notification clearances for medical devices, with the applicant/manufacturer, device name, clearance number (K-number), decision (date + description), clearance type, product code, advisory committee, and geography (openFDA /device/510k.json; api.fda.gov). KEYLESS (optional free OPENFDA_API_KEY only raises the rate limit — keyless works at ~1000 requests/day; NEVER throws for a missing key). Input: STRUCTURED filters — applicant, deviceName, productCode, clearanceType (e.g. Traditional/Special/Abbreviated), kNumber (e.g. 'K123456'), state (2-letter) — safely escaped into the openFDA search= Lucene string (NO raw passthrough), plus limit (1..100, default 25) and skip (offset ≥0). Returns { clearances:[{ applicant, deviceName, kNumber, decisionDate, decisionDescription, clearanceType, productCode, advisoryCommittee, state }] } + honest _meta. HONESTY: totalAvailable is openFDA's EXACT meta.results.total (skip/limit pagination via hasMore/nextOffset — never results.length); every scalar is null-never-empty-string; decision_date is a YYYY-MM-DD string. ★A no-match query returns openFDA HTTP 404 → HONEST EMPTY (returned:0/total:0), NOT an error; 400 → invalid_input surfacing openFDA's message; 5xx → THROWS; 200 non-JSON → schema_drift. Optional key rides ONLY in &api_key= param.
Input Schema
| Name | Required | Description | Default |
|---|---|---|---|
| skip | No | Row offset for pagination (default 0). Page with _meta.pagination.nextOffset. | |
| limit | No | Max clearance records to return (default 25, max 100). Offset-paginated via skip. | |
| state | No | 2-letter US state/territory postal code filter (→ state), e.g. 'CA'. Validated ^[A-Za-z]{2}$. | |
| kNumber | No | 510(k) clearance number (K-number) filter (→ k_number), e.g. 'K123456'. Matched as an escaped Lucene phrase. | |
| applicant | No | Applicant / manufacturer name filter (→ applicant), e.g. 'medtronic'. Matched as an escaped Lucene phrase. | |
| deviceName | No | Device name filter (→ device_name), e.g. 'catheter'. Matched as an escaped Lucene phrase. | |
| productCode | No | FDA product code filter (→ product_code), e.g. 'DXN'. Matched as an escaped Lucene phrase. | |
| clearanceType | No | 510(k) clearance type filter (→ clearance_type), e.g. 'Traditional', 'Special', 'Abbreviated'. Matched as an escaped Lucene phrase. |