`fda_device_510k_search`

Pack: fda-devices · Connect: https://pipeworx.io/mcp (see Connect below for a single-pack URL)

No MCP client? Call it directly: GET https://gateway.pipeworx.io/v1/tools/fda_device_510k_search for the schema, then POST the same URL with its arguments for the data.

Search 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.

Parameters

Name	Type	Required	Description
`device`	string	no	Device/trade name substring.
`indication`	array	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.
`items`	string	no
`applicant`	string	no	Applicant/company substring.
`product_code`	string	no	Exact three-letter FDA product code.
`k_number`	string	no	Exact K number, e.g. K241234, or De Novo number, e.g. DEN250057.
`from_date`	string	no	Earliest decision date, YYYY-MM-DD.
`to_date`	string	no	Latest decision date, YYYY-MM-DD.
`advisory_committee`	string	no	FDA review panel name (exact), e.g. “Orthopedic” or “Microbiology”.
`clearance_type`	string	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.
`decision`	string	no	Exact decision text, e.g. “Substantially Equivalent”, or “Granted” for a De Novo grant.
`applicant_country`	string	no	Applicant country, ISO 3166-1 alpha-2 code, e.g. “US” or “JP”.
`applicant_state`	string	no	Applicant US state/territory code, e.g. “CA”. Only populated for US applicants.
`third_party_review`	boolean	no	true to keep only 510(k)s reviewed under FDA’s third-party review program; false to exclude them.
`limit`	number	no	Results (1-100, default 20).
`skip`	number	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.

Example call

Arguments

{
  "device": "glucose monitor",
  "from_date": "2025-01-01",
  "limit": 10
}

curl

curl -X POST https://gateway.pipeworx.io/fda-devices/mcp \
  -H 'Content-Type: application/json' \
  -d '{"jsonrpc":"2.0","id":1,"method":"tools/call","params":{"name":"fda_device_510k_search","arguments":{"device":"glucose monitor","from_date":"2025-01-01","limit":10}}}'

TypeScript (@pipeworx/sdk)

import { Pipeworx } from '@pipeworx/sdk';
const pipeworx = new Pipeworx();

const result = await pipeworx.call('fda_device_510k_search', {
  "device": "glucose monitor",
  "from_date": "2025-01-01",
  "limit": 10
});

More examples

{
  "advisory_committee": "Orthopedic",
  "clearance_type": "Special",
  "limit": 5
}

{
  "indication": [
    "insulin pump"
  ],
  "limit": 5
}

{
  "k_number": "DEN250057"
}

Connect

Add this to your MCP client config — every tool in the catalog, including this one — or use one-click install buttons:

{
  "mcpServers": {
    "pipeworx": {
      "url": "https://pipeworx.io/mcp"
    }
  }
}

Connect to just the fda-devices pack

{
  "mcpServers": {
    "fda-devices": {
      "url": "https://gateway.pipeworx.io/fda-devices/mcp"
    }
  }
}

See Getting Started for client-specific install steps.

fda_device_510k_search