`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, or K number. Clearance means FDA found substantial equivalence; it is not an FDA approval or endorsement.

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.
`limit`	number	no	Results (1-100, default 20).

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
});

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