# Fda Devices

> FDA medical-device regulatory intelligence from keyless openFDA datasets.

- name: io.github.pipeworx-io/fda-devices
- version: 0.1.7
- connection class: R0 (autonomous)
- trust: 97/100
- quality: –/100 (not scored)
- owner: not claimed
- descriptor: https://api.protogrid.dev/v1/servers/io.github.pipeworx-io%2Ffda-devices
- tools: https://api.protogrid.dev/v1/servers/io.github.pipeworx-io%2Ffda-devices/tools

**An agent can connect right now, no human step.** Remote endpoint, no authentication, reachable on the last probe.

## Connection (mcpServers)

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


## Trust

- hygiene: 100
- liveness: 99
- freshness: 100
- provenance: 90
- drivers: +repository +namespace-matches-repo +website +reachable +uptime-97% +updated-24d-ago
- Derived from observable signals (official registry feed and our own credential-free probes); no code audit performed.

## Quality –/100 (not scored)

Not scored: fewer than three checks apply, usually because no remote answered a credential-free probe or the server is a local package.

### protocol: 75 (weight 25)

- warn `protocol.modern`: newest supported version is 2025-03-26; 2026-07-28 not supported, older versions are deprecated until 2027-07-28
- n/a `protocol.stateless`: only applies to 2026-07-28 servers
- pass `protocol.transport`: streamable HTTP
- n/a `protocol.list_ttl`: only applies to 2026-07-28 servers

### authorization: n/a (weight 15)

- n/a `auth.prm`, `auth.as_metadata`, `auth.cimd`: no remote uses OAuth
- n/a `auth.secret_in_url`: no templated URL

### tool hygiene: n/a (weight 30)

- n/a `tools.descriptions`, `tools.description_length`, `tools.schemas`, `tools.annotations`, `tools.directory_hints`, `tools.token_cost`, `tools.api_dump`: tool list unknown (behind auth, not probed, or empty)

### stability: n/a (weight 15)

- n/a `stability.changes`, `stability.rug_pull`: tool list unknown

### dependencies: n/a (weight 15)

- n/a `deps.known_vulns`, `deps.mcp_sdk_version`, `deps.resolvable`: no npm or PyPI package

- tools: unknown
- tools last changed: 2026-10-20T06:47:38.972Z
- badge: [![protogrid quality](https://protogrid.dev/badge/io.github.pipeworx-io/fda-devices.svg)](https://protogrid.dev/servers/io.github.pipeworx-io/fda-devices)
- Checks run on what our credential-free, read-only probes observe; tools are never called and no code audit is performed.

### Tool changes

- 2026-10-20 `fda_device_product_code_profile` removed
  - 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.
- 2026-10-20 `fda_device_establishment_search` removed
  - 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.
- 2026-10-20 `fda_device_udi_search` removed
  - 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.
- 2026-10-20 `fda_device_classification` removed
  - 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.
- 2026-10-20 `fda_device_company_profile` removed
  - 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.
- 2026-10-20 `fda_device_adverse_events` removed
  - 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.
- 2026-10-20 `fda_device_recalls` removed
  - 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.
- 2026-10-20 `fda_device_pma_search` removed
  - 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 companion diagnostics and molecular residual disease (MRD) / ctDNA monitoring tests (e.g. Signatera, Guardant360 CDx) -- these are FDA-approved tests, not cleared devices, so this tool (not 510(k)) is the one that finds them. `indication` matches free text in FDA's own published approval-order narrative (`ao_statement`) -- the intended-use/indication language FDA wrote when it approved the device -- so a caller who describes what a test DOES or what condition/biomarker it monitors (without knowing any brand name) can still find it; `device` only matches the trade/generic NAME field and returns nothing for a condition-only question. Supplements may represent manufacturing or labeling changes rather than new devices, so a supplement's own ao_statement can be a narrow procedural note (e.g. "approval of a post-approval study protocol") rather than the full clinical indication -- pass several synonymous indication phrases (FDA's exact wording varies by product and rarely matches a lay term) rather than one exact phrase.
- 2026-10-20 `fda_device_510k_summary` removed
  - 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.
- 2026-10-20 `fda_device_510k_search` removed
  - 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/hardware -- includes cleared molecular, genomic and companion diagnostic tests. Clearance means FDA found substantial equivalence; it is not an FDA approval or endorsement. `indication` is a BEST-EFFORT bridge, not a clinical-claim search: 510(k) records carry no indication/intended-use text at all, so it matches FDA's device CLASSIFICATION category name/definition instead (a product TYPE like "Insulin Pump", not a specific claim) and finds clearances under the matching product code(s) -- for a true clinical-indication text search (e.g. molecular/companion-diagnostic claims), use fda_device_pma_search's indication argument, which searches FDA's real approval-order narrative. Unknown arguments are rejected, not ignored. The most recent decision available lags roughly 2 weeks behind FDA's own site (openFDA's publishing cadence, not ours) -- do not treat this as same-day. `total` can exceed the 100-row `limit` cap; page further rows with `skip`.

Full history: https://api.protogrid.dev/v1/servers/io.github.pipeworx-io%2Ffda-devices/changes

## Remotes

- https://gateway.pipeworx.io/fda-devices/mcp (streamable-http, auth none, reachable true, uptime30d 0.974359)

## Packages

_none_

## Tools (0)

_none observed_