Not medical or regulatory advice; check the device's listing on the FDA database before relying on it.

Medical Device Clearances & Registrations (510(k), PMA)

US medical device 510(k) clearances, PMA approvals, establishment registrations and product codes from US government public data. Business fields only. Unofficial.

Modes (endpoint)

• clearances: 510(k) clearances; pages automatically up to Max results
• clearance-detail: 510(k) by K number (ids: K numbers, e.g. K243456)
• approvals: PMA approvals; pages automatically up to Max results
• approval-detail: PMA by number (ids: PMA numbers, e.g. P200001)
• registrations: Establishment registrations; pages automatically up to Max results
• registration-detail: Registration by number (ids: registration numbers)
• product-codes: Product codes

Filters are passed as JSON in filters, using the same names as the output's query object (e.g. {"q":"catheter"}).

Output. One row per record (type: "record"), plus source_notice and removal on every row. Free status rows (never charged): invalid-input, not-found, no-results, api-error, service-busy, run-limit-reached, free-plan-limit, charge-limit-reached.

Example row:

{
 "k_number": "K262913",
 "decision_date": "2026-09-17",
 "date_received": "2026-08-19",
 "decision_code": "SESE",
 "decision": "Substantially Equivalent",
 "clearance_type": "Special",
 "device_name": "Stents, Drains And Dilators For The Biliary Ducts",
 "product_code": "FGE",
 "applicant": "Medtronic, Inc.",
 "city": "Plymouth",
 "state": "MN",
 "zip": "55441",
 "country_code": "US",
 "advisory_committee": "Gastroenterology, Urology",
 "statement_or_summary": "Summary",
 "third_party_review": false,
 "expedited_review": false,
 "device_class": "2",
 "regulation_number": "876.5010",
 "medical_specialty": "Gastroenterology, Urology",
 "device_name_classification": "Stents, Drains And Dilators For The Biliary Ducts",
 "document_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262913"
}

Data source, notices and limits

• US government public data: medical device premarket clearances (510(k), De Novo) and approvals (PMA), establishment registrations and device listings, and device classification, from the U.S. Food and Drug Administration (the source publishes it under CC0 1.0).
• Data provided by the U.S. Food and Drug Administration (https://open.fda.gov).
• Unofficial. Not affiliated with, endorsed by, or sponsored by the U.S. Food and Drug Administration or any government agency.
• Live from the public source (updated weekly or monthly), cached up to 24 hours; retrieved_at shows when, source_last_updated shows the source date.
• Company-level data. No contact persons, US agent persons, official correspondents, phone numbers, faxes or emails. Applicant street lines and ZIP+4 omitted (5-digit ZIP kept); registered establishment address kept.
• Removal requests: support@lepidata.com (handled within 30 days).
• Unofficial data provided as is. Not medical, legal or regulatory advice. A clearance or registration is not an endorsement of a device. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.
• Records listed for removal on request are filtered out of every run.
• Source capacity is shared by all users of this tool. When it runs low or the source rate limits, runs stop cleanly with a free service-busy row. Hard cap: 500 source calls per run, paced (about one call every 0.5 s).
• Free-plan accounts get up to 100 results per run.

Pricing. Pay per result row, flat on every plan, no start fee. Status rows are free.

Contact: support@lepidata.com