MCP server

Fda Devices

io.github.pipeworx-io/fda-devices

Checked 26 Oct 2026, 08:29 UTC · Connected to it and listed its tools

FDA medical-device regulatory intelligence from keyless openFDA datasets.

Website Source

At a glance

Type

MCP server

Publisher

pipeworx.io (verified by the MCP Registry)

Status

Working at last check

Tools

53

Token cost

About 30,228 tokens per request

Sets up in

Claude Code, Claude Desktop, Codex, Gemini CLI, Cursor, VS Code, Antigravity, ChatGPT, OpenAI API, Grok

Last checked

26 Oct 2026, 08:29 UTC

Connect it to your agent

Add to CursorAdd to VS CodeVS Code Insiders

Opens the app, which shows the server and asks you to confirm. For other apps, copy the setup below.

Claude Code

claude mcp add --transport http fda-devices https://gateway.pipeworx.io/fda-devices/mcp

Claude Desktop

Settings → Connectors → Add custom connector, and paste the URL.

Codex (config.toml)

[mcp_servers.fda-devices]
url = "https://gateway.pipeworx.io/fda-devices/mcp"

Gemini CLI

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

Cursor

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

VS Code

{"servers":{"fda-devices":{"type":"http","url":"https://gateway.pipeworx.io/fda-devices/mcp"}}}

Antigravity

agy mcp add fda-devices https://gateway.pipeworx.io/fda-devices/mcp

ChatGPT

Settings → Apps & Connectors → Advanced settings: turn on Developer mode, then Create a connector and paste the URL. Which plans can do this varies.

OpenAI API (Responses tools)

{"type":"mcp","server_label":"fda-devices","server_url":"https://gateway.pipeworx.io/fda-devices/mcp","require_approval":"always"}

Grok (xAI API tools)

{"type":"mcp","server_label":"fda-devices","server_url":"https://gateway.pipeworx.io/fda-devices/mcp"}

Tools

• fda_device_510k_search ~1244 tokens
  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/
• fda_device_510k_summary ~180 tokens
  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 clea
• fda_device_adverse_events ~268 tokens
  Search FDA MAUDE medical-device reports by manufacturer, brand/device, product code, event type, or PMA/510(k) number. MAUDE reports are unverified signals: they cannot establish causation, incidence, prevalence, or comparative safety.
• fda_device_classification ~146 tokens
  Look up FDA device classification and regulatory context by product code, device name, or regulation number. Classification describes the product-code category, not a specific product’s clearance or approval.
• fda_device_company_profile ~151 tokens
  Build a bounded FDA regulatory snapshot for one device company across 510(k), PMA, recalls, and MAUDE. Dataset name matching is imperfect and MAUDE counts are signals, not safety rates.
• fda_device_establishment_search ~148 tokens
  Search FDA device registration/listing data by firm, registration number, product code, or listing number. Registration/listing does not mean FDA approval, clearance, certification, or endorsement.
• fda_device_event_counts ~347 tokens
  Aggregate MAUDE reports for a device query by event type, manufacturer, product code, or receive date. Counts reflect reporting and database artifacts—not event rates or causal risk—and must not be compared without exposure denominators.
• fda_device_pma_search ~876 tokens
  Search FDA Premarket Approval (PMA) decisions and supplements by trade/generic name, applicant, product code, PMA number, or CLINICAL INDICATION/condition text (via `indication`). Which diagnostic tests are FDA-approved: covers high-risk IN VITRO DIAGNOSTIC (IVD) tests approved via PMA, including co
• fda_device_product_code_profile ~134 tokens
  Build a bounded cross-dataset snapshot for one FDA product code: classification, recent 510(k)s, PMAs, recalls, and MAUDE reports. Dataset counts have different meanings; MAUDE counts are not event rates.
• fda_device_recalls ~272 tokens
  Search FDA medical-device recall records by firm, product, product code, K number, status, or date. A recall record describes a correction/removal action and does not by itself establish patient harm.
• fda_device_udi_search ~159 tokens
  Search FDA GUDID/UDI records by brand, company, device identifier, or product code. A UDI record describes an identified device in GUDID; it does not establish current sales, availability, clearance, approval, or safety.

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