`fda_device_510k_search`

Pack: fda-devices · Endpoint: https://gateway.pipeworx.io/fda-devices/mcp

Search FDA 510(k) premarket notifications by device, applicant, product code, K number, review panel, clearance type, decision, applicant location, or third-party review status. Clearance means FDA found substantial equivalence; it is not an FDA approval or endorsement. 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.
`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.
`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 clearance type: Traditional, Special, or Abbreviated.
`decision`	string	no	Exact decision text, e.g. “Substantially Equivalent”.
`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
}

Connect

Add this to your MCP client config, or use one-click install buttons:

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

See Getting Started for client-specific install steps.

fda_device_510k_search