@pipeworx/fda-devices

Connect: https://pipeworx.io/mcp — every tool in the catalog, including @pipeworx/fda-devices’s. Install: one-click buttons

No MCP client? Skip the connection: POST https://gateway.pipeworx.io/v1/tools/search_packs {"query":"..."} to find a tool below, GET /v1/tools/<name> for its schema, POST the same URL with arguments for the data — see For AI agents.

Tools: 11

@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.

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.

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”.

Tools

• fda_device_510k_search — 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 (
• fda_device_510k_summary — 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. Show
• fda_device_pma_search — 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 tes
• fda_device_recalls — 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_adverse_events — 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,
• fda_device_event_counts — 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 co
• fda_device_company_profile — 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_classification — 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 a
• fda_device_udi_search — 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,
• fda_device_establishment_search — 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_product_code_profile — 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 ra