@pipeworx/fda-devices

FDA medical-device regulatory intelligence: 510(k) premarket clearances (including De Novo classification requests), PMA approvals, recalls, MAUDE adverse-event reports, device classification, GUDID/UDI identifiers, and establishment registration/listing. Keyless.

Part of Pipeworx — an MCP gateway connecting AI agents to 1864+ live data sources. This is an independent, unofficial integration — not affiliated with, endorsed by, or published by the upstream provider.

Tools

• fda_device_510k_search(device?, indication?, applicant?, product_code?, k_number?, from_date?, to_date?, advisory_committee?, clearance_type?, decision?, applicant_country?, applicant_state?, third_party_review?, limit?, skip?) — search 510(k) premarket notifications. Also covers De Novo classification requests (K numbers beginning DEN, e.g. DEN250057) — pass clearance_type: "De Novo" to find only these, or an exact k_number. A granted De Novo shows decision: "Granted", clearance_type: "De Novo", the FDA process variant in de_novo_pathway ("Direct" or "Post-NSE"), and the new device-classification regulation_number it created.

• fda_device_510k_summary(k_number) — the actual 510(k) summary/statement and FDA review (decision memo) document for one clearance, scraped off FDA's own detail page since openFDA does not expose the file itself. Older/paper-only filings return summary_available: false with a reason, not an error.

• fda_device_pma_search(device?, indication?, applicant?, product_code?, pma_number?, from_date?, to_date?, limit?) — search Premarket Approval (PMA) decisions and supplements, including by the FDA approval-order narrative text (indication) for high-risk IVD/companion-diagnostic claims.

• fda_device_recalls(query?, firm?, product_code?, k_number?, status?, from_date?, limit?) — medical-device recall (correction/removal) records.

• fda_device_adverse_events(device?, manufacturer?, product_code?, event_type?, application_number?, from_date?, limit?) — MAUDE adverse-event reports. Signals, not causal safety rates.

• fda_device_event_counts(query?, count_field, limit?) — aggregate MAUDE reports by device, manufacturer, event type, product code, or date.

• fda_device_company_profile(company, limit_per_dataset?) — bounded cross-dataset snapshot (510(k)/De Novo, PMA, recalls, MAUDE) for one company.

• fda_device_classification(product_code?, device?, regulation_number?, limit?) — FDA device classification/regulatory category lookup.

• fda_device_udi_search(query?, company?, primary_di?, product_code?, limit?) — GUDID/UDI device identifier records.

• fda_device_establishment_search(firm?, registration_number?, product_code?, listing_number?, limit?) — device registration/listing records.

• fda_device_product_code_profile(product_code, limit_per_dataset?) — bounded cross-dataset snapshot (classification, 510(k)/De Novo, PMA, recalls, MAUDE) for one product code.

Every call rejects unknown argument names rather than silently ignoring them.

Related MCP server: fda-approvals-mcp

Auth

Keyless.

Data sources

• U.S. Food and Drug Administration (FDA), openFDA device datasets — 510(k) premarket notification (which also carries De Novo classification requests), Premarket Approval (PMA), medical device recall enforcement reports, MAUDE adverse event reports, device classification, GUDID/UDI, and device registration & listing.

• U.S. FDA CDRH, 510(k) Premarket Notification database — the authoritative detail page for one clearance's summary/review document link, used only by fda_device_510k_summary because openFDA itself does not expose the document.

Gotchas

• De Novo records share the 510(k) endpoint, and openFDA's own decision/clearance-type text for them is wrong on its face. A De Novo grant's K number begins DEN (e.g. DEN250057), and openFDA's decision_code for every one of them is DENG — but openFDA's own decision_description lookup for that code (and five older legacy 510(k) codes: Kit, Kit-With-Drugs, With-Drug, With-Limitations, Postmarket-Surveillance-Required) is the literal string "Unknown", and its clearance_type for a De Novo record is "Direct" or "Post-NSE" — FDA's own PROCESS VARIANT for how the De Novo was handled, not a 510(k) clearance type. Confirmed live 2026-10-21 against FDA's own De Novo detail page, which labels the decision literally "granted (DENG)". This pack maps decision_code through its own label table (decision: "Granted") and remaps clearance_type to "De Novo" with the process variant preserved in de_novo_pathway, rather than passing openFDA's confusing raw text through. clearance_type: "De Novo" and decision: "Granted" as filter arguments are translated to the matching decision_code/clearance_type values server-side, since openFDA itself stores neither string literally.

• indication on 510(k) is a best-effort device-category bridge, not a clinical-claim search — 510(k) records carry no indication/intended-use text at all. It matches FDA's device classification category name/definition instead. For a real clinical-indication text search (useful for molecular/companion-diagnostic claims), use fda_device_pma_search's indication, which searches FDA's actual approval-order narrative.

• MAUDE's manufacturer_name field is populated on essentially no records (25.7M rows, almost all empty string) while device.manufacturer_d_name is the real one — fda_device_adverse_events's manufacturer argument searches the latter. A dead field 404s identically to "no matches", so every response names which fields were actually searched.

• The most recent decision available lags roughly two weeks behind FDA's own site — openFDA's publishing cadence, not ours.

• fda_device_510k_summary's K-number PDF directory path is not derivable from the K number (year-segment naming is inconsistent, pre-2000 filings have no year segment at all) — the tool scrapes the actual link off FDA's detail page rather than guessing a path that could 404 for either "wrong guess" or "never digitized".

Quick Start

Add to your MCP client (Claude Desktop, Cursor, Windsurf, etc.):

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

What this endpoint actually serves

tools/list at https://gateway.pipeworx.io/fda-devices/mcp returns the tools in the table above plus the shared Pipeworx meta-tools — ask_pipeworx, discover_tools, search_within, remember/recall and the rest of the gateway-wide set. So the tool count you see is larger than this table: a single-pack endpoint currently lists roughly 30 shared tools alongside the pack's own. The connection's initialize response states its exact scope, and is the authoritative answer for a given day.

This is deliberate, not multiplexing by accident. The meta-tools are what let a scoped connection answer a question this pack does not cover — via ask_pipeworx, which routes across the whole catalog — without you adding a second MCP server. There is currently no way to mount a pack endpoint without them; if the extra schemas cost you more context than the routing is worth, connect to the full gateway once rather than to several pack endpoints.

Or connect to the full Pipeworx gateway to get every pack's tools listed directly, instead of just this one's:

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

Both URLs reach the same gateway and the same 1864+ data sources. The only difference is which pack's tools are listed directly; ask_pipeworx reaches all of them from either one.

No MCP client? Call it over HTTP

curl -X POST https://gateway.pipeworx.io/v1/tools/fda_device_510k_search \
  -H 'Content-Type: application/json' \
  -d '{"device":"glucose monitor","from_date":"2025-01-01","limit":10}'

No account needed for the first calls. Inspect any tool: GET https://gateway.pipeworx.io/v1/tools/fda_device_510k_search. Find one: POST https://gateway.pipeworx.io/v1/tools/search_packs with {"query":"..."}.

Run it from npm

@pipeworx/mcp-fda-devices is a local stdio bridge to the Pipeworx gateway: your MCP client starts it with npx, and it forwards every call to the same https://gateway.pipeworx.io/fda-devices/mcp endpoint shown above. It needs network access; there is no offline mode.

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

Without a key it calls anonymously, capped at 50 calls a day. A free account raises that to 200 a day: get a key at https://pipeworx.io/signup and add "env": { "PIPEWORX_API_KEY": "<your key>" } to the server entry. The key is sent as a Bearer token, the same way a hosted connection sends it, so calls are metered and billed exactly as they are there.

It lists only this pack's tools by default. Set PIPEWORX_META_TOOLS=1 to also list ask_pipeworx and the other gateway-wide tools.

Behind an HTTPS proxy: Node's built-in fetch does not read HTTPS_PROXY by default. Newer Node releases honour it when NODE_USE_ENV_PROXY=1 is set; check your Node version's documentation.

Using with ask_pipeworx

Instead of calling tools directly, you can ask questions in plain English — this works on the pack endpoint above as well as on the full gateway:

ask_pipeworx({ question: "your question about Fda Devices data" })

The gateway picks the right tool and fills the arguments automatically.

More

• Docs and guides

• pipeworx.io

License

MIT