What it returns
Every FDA medical device 510(k) clearance and PMA decision, from openFDA, in clean JSON.
Type (510k or PMA), K or P number, supplement, company, device and generic name, product code, device class, regulation number, medical specialty and review panel, **date received and decision date**, decision, clearance type, expedited and third-party review flags, location, and a link to the FDA record.
Common uses
Track clearances and approvals for medtech companies you follow. Competitive intelligence by product code (for example every radiology triage software clearance). Event studies: decision dates for original PMAs.
Request
POST https://api.pushbuild.com/fda-device-clearances/run with a JSON body. Send your key in the X-API-Key header.
| Field | Type | Description |
|---|---|---|
dataset | string: both, 510k, pma | Which decisions to return. Default: "both". |
applicant | string | e.g. Medtronic, Boston Scientific. |
deviceName | string | Matches the device, trade or generic name. |
productCodes | list of strings | Three-letter product codes, e.g. QAS (radiology triage software). |
advisoryCommittee | string | Two-letter code, e.g. CV (cardiovascular), RA (radiology), OR (orthopedic). |
decisionCode | string | e.g. SESE (substantially equivalent). 510(k) only. |
originalPmaOnly | boolean | Skip PMA supplements and 30-day notices. Default: false. |
dateFrom | string | YYYY-MM-DD. Default: 30 days ago. |
dateTo | string | YYYY-MM-DD. Default: today. |
sort | string: newest, oldest | By decision date. Default: "newest". |
maxItems | integer | Maximum items to return (1-500). Default: 100. |
Example
curl -X POST https://api.pushbuild.com/fda-device-clearances/run \
-H "X-API-Key: YOUR_KEY" \
-H "Content-Type: application/json" \
-d '{"applicant": "Medtronic", "maxItems": 20}'Response
{"count": 20, "truncated": false, "seconds": 1.4, "items": [ { ... } ]}Each call returns up to 500 items. Records that fail validation or are not found are flagged in the items and not charged.
Pricing
Pay only for results returned: $0.24 per 1,000 decisions. No charge for errors or empty searches.
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