fda_device_510k_summary

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_summary for the schema, then POST the same URL with its arguments for the data.

Get the FDA 510(k) summary/statement document and FDA review (decision memo) for one clearance, by K number — the actual filing, not just the “a document exists” flag from fda_device_510k_search. Shows the predicate device claimed and the testing behind the equivalence finding. Older/paper-only clearances were never digitized; that returns summary_available:false with a reason, not an error.

Parameters

Example call

Arguments

{
  "k_number": "K253470"
}

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_summary","arguments":{"k_number":"K253470"}}}'

TypeScript (@pipeworx/sdk)

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

const result = await pipeworx.call('fda_device_510k_summary', {
  "k_number": "K253470"
});

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"
    }
  }
}

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

See Getting Started for client-specific install steps.