Fda Devices

What Fda Devices MCP server does

The Fda Devices MCP server gives MCP clients access to keyless openFDA data for medical-device regulatory research. Its tools cover both premarket pathways and postmarket records, including 510(k) notifications, PMA decisions and supplements, recalls, MAUDE reports, device classifications, UDI records, and establishment registration/listing data.

The Fda Devices MCP server also provides bounded profiles. A company profile combines 510(k), PMA, recall, and MAUDE information for one company. A product-code profile combines classification, recent 510(k)s, PMAs, recalls, and MAUDE records for one FDA product code.

How it works

Connect an MCP client to the Pipeworx endpoint at https://gateway.pipeworx.io/fda-devices/mcp, or use the full gateway at https://gateway.pipeworx.io/mcp. The pack endpoint exposes the device tools along with shared Pipeworx meta-tools. The full gateway lists the broader catalog directly. The gateway can also route natural-language questions through ask_pipeworx.

For a local deployment, run the npm package with npx -y @pipeworx/mcp-fda-devices. The local process communicates over stdin and stdout and exposes only the tools in this pack. The same capabilities can also be called over HTTP through the gateway's tool API.

Setup and configuration

A remote MCP client can use this configuration:

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

For local stdio operation:

{
  "mcpServers": {
    "fda-devices": {
      "command": "npx",
      "args": ["-y", "@pipeworx/mcp-fda-devices"]
    }
  }
}

No environment variables are specified for the standalone package.

Tools and capabilities

• Search 510(k) records by device, applicant, product code, K number, panel, decision, clearance type, location, or category-related text.
• Retrieve a 510(k) summary and FDA review document for a K number when the material is available.
• Search PMA decisions and supplements by name, applicant, product code, PMA number, or clinical-indication text.
• Search recalls, MAUDE adverse events, and aggregated MAUDE event counts.
• Look up product classification, UDI records, and establishment registration/listing records.
• Build company and product-code regulatory snapshots across multiple datasets.

Limitations and notes

510(k) clearance indicates substantial equivalence, not FDA approval or endorsement. The 510(k) indication parameter is a best-effort category bridge because those records do not contain clinical-indication text; PMA indication searches FDA approval-order narrative instead. Recent 510(k) decisions may lag the FDA site by roughly two weeks, and result pages are capped at 100 rows, requiring skip for additional results.

Older paper-only 510(k) records may have no digitized summary. MAUDE reports are unverified signals and cannot establish causation, rates, prevalence, or comparative safety. Event counts reflect reporting and database artifacts and require exposure denominators for meaningful comparison. Recalls describe correction or removal actions and do not alone demonstrate patient harm. Registration, listing, UDI, and classification records do not establish approval, clearance, certification, endorsement, current availability, or safety. Dataset name matching in company profiles is imperfect.

The Fda Devices MCP server is licensed under MIT.