Fda Device 510k Search
fda_device_510k_searchSearch FDA 510(k) premarket notifications by device, applicant, product code, K number, review panel, clearance type, decision, applicant location, third-party review status, or device-category text (via indication). Covers IN VITRO DIAGNOSTIC (IVD) tests and diagnostic devices, not just implants/hardware -- includes cleared molecular, genomic and companion diagnostic tests. Clearance means FDA found substantial equivalence; it is not an FDA approval or endorsement. ALSO covers De Novo classification requests (K numbers beginning "DEN", e.g. DEN250057) -- these are not 510(k) clearances but a separate pathway that creates a brand-new device classification when no predicate exists; pass clearance_type:"De Novo" to find only these, or k_number for one by its DEN number. A granted De Novo shows decision "Granted" and carries the new regulation_number it created. indication is a BEST-EFFORT bridge, not a clinical-claim search: 510(k) records carry no indication/intended-use text at all, so it matches FDA's device CLASSIFICATION category name/definition instead (a product TYPE like "Insulin Pump", not a specific claim) and finds clearances under the matching product code(s) -- for a true clinical-indication text search (e.g. molecular/companion-diagnostic claims), use fda_device_pma_search's indication argument, which searches FDA's real approval-order narrative. Unknown arguments are rejected, not ignored. The most recent decision available lags roughly 2 weeks behind FDA's own site (openFDA's publishing cadence, not ours) -- do not treat this as same-day. total can exceed the 100-row limit cap; page further rows with skip.
Input Schema
| Name | Required | Description | Default |
|---|---|---|---|
| skip | No | Row offset for paging past the 100-row limit cap (openFDA `skip`, max 25000), e.g. skip=100 with limit=100 returns rows 101-200. | |
| limit | No | Results (1-100, default 20). | |
| device | No | Device/trade name substring. | |
| to_date | No | Latest decision date, YYYY-MM-DD. | |
| decision | No | Exact decision text, e.g. "Substantially Equivalent", or "Granted" for a De Novo grant. | |
| k_number | No | Exact K number, e.g. K241234, or De Novo number, e.g. DEN250057. | |
| applicant | No | Applicant/company substring. | |
| from_date | No | Earliest decision date, YYYY-MM-DD. | |
| indication | No | One or more device-category phrases, OR'd together, matched against FDA's device classification name/definition (device/classification.json) to find matching product code(s), then 510(k)s under those codes -- a category match (e.g. "Insulin Pump"), NOT a search of clinical-claim text, because 510(k) has no such field. Pass several phrasings since matching is exact-phrase against the category wording. For an actual clinical-indication/intended-use text search, use fda_device_pma_search's indication argument instead. | |
| product_code | No | Exact three-letter FDA product code. | |
| clearance_type | No | Exact pathway: Traditional, Special, Abbreviated, or Dual Track for ordinary 510(k)s; "De Novo" for a De Novo classification request/grant (DEN numbers) regardless of whether FDA processed it as "Direct" or "Post-NSE" -- both come back labelled De Novo, with the FDA pathway variant in de_novo_pathway. | |
| applicant_state | No | Applicant US state/territory code, e.g. "CA". Only populated for US applicants. | |
| applicant_country | No | Applicant country, ISO 3166-1 alpha-2 code, e.g. "US" or "JP". | |
| advisory_committee | No | FDA review panel name (exact), e.g. "Orthopedic" or "Microbiology". | |
| third_party_review | No | true to keep only 510(k)s reviewed under FDA's third-party review program; false to exclude them. |
Output Schema
| Name | Required | Description | Default |
|---|---|---|---|
| total | Yes | ||
| source | Yes | ||
| returned | Yes | ||
| clearances | Yes |