Constat MCP — FDA Device Evidence Lifecycle

Last 30 days

Status and outage history · Atom feed

Uptime

100%

Response time

490 ms typical, 634 ms slowest 5%

Last check

5 min ago

Next check

in 5 h

How to call it

Add it to any MCP client that supports remote servers.

{
  "mcpServers": {
    "constat-mcp-fda-device-evidence-lifecycle": {
      "type": "http",
      "url": "https://constat.dev/api/mcp"
    }
  }
}

14 tools

• device_risk_lookup

  Review a medical-device category's public FDA signals by three-letter product code (e.g. FRN = infusion pump). Returns recalls, MAUDE adverse-event trend, warning-letter matches, a normalized category signal, its driver contributions, and interpretation limits. It does not predic

• firm_compliance_history

  Build a recent, source-bounded FDA public-record timeline for a device firm: matched recalls, warning letters, and Form 483 citations where exact FEI numbers are available. Product codes are discovered from Constat's AI/ML-device corpus or may be supplied explicitly. Returns attr

• watchlist_diff

  Return machine-generated FDA public-record changes detected for monitored product codes since a caller-supplied date, plus each code's latest category snapshot and postmarket coverage. Defaults to Constat Radar's five-code watchlist and the last seven days. Analyst verdict text a

• device_evidence_lookup

  Look up the structured premarket evidence FDA accepted for a specific AI/ML-enabled device by 510(k) number (e.g. K252148). Returns parsed summary fields — validation study design, sample sizes, endpoints, reported performance, predicate chain, PCCP — each with a verbatim source

• evidence_search

  Find AI/ML device clearances by filter — product code, panel, applicant, and whether the submission reported clinical data, any sensitivity metric, or a PCCP. Answers 'what evidence did FDA accept for devices like mine'. Returns bounded discovery summaries; call device_evidence_l

• predicate_chain

  Trace the predicate ancestry of a 510(k) device, with each cited predicate's age (how many years old the predicate was when the child cleared). Reveals how AI/ML devices chain to older predicates.

• evidence_cohort_stats

  Reporting-rate stats across the parsed AI/ML corpus (optionally by panel). Each rate is a presence figure with its denominator — 'reported in X of Y audited devices' — never a pooled performance value. Excludes not-yet-parsed devices from every denominator and discloses the parse

• device_postmarket_lookup

  Post-clearance intelligence for one AI/ML device by 510(k) number: its product code's recalls, MAUDE adverse-event level and trend, warning-letter and 483 matches for the applicant, plus per-device drift signals (adverse-event inflection, re-clearances of the same device line, so

• postmarket_search

  Find AI/ML devices by postmarket criteria — product code, panel, applicant, whether any drift signal exists, minimum recalls in 24 months, or a rising MAUDE trend. Returns per-device postmarket summaries with drift-signal counts.

• cohort_postmarket_stats

  Postmarket presence rates across the snapshotted AI/ML device cohort (optionally by panel): share with any recall in 24 months, with a rising MAUDE trend, with any drift signal, with a warning-letter match — every rate with its denominator inline, never pooled across devices.

• reimbursement_lookup

  Trace the clearance-to-payment pathway for an AI/ML device by FDA clearance number (K/DEN, e.g. DEN170073) OR bare CPT code (e.g. 75580). Returns every payment mechanism (NTAP add-on, Category I/III CPT + CMS rate, HCPCS, MAC LCD) with amounts, effective dates, and source links,

• reimbursement_search

  Find AI/ML device payment pathways by mechanism — e.g. 'devices that got NTAP', 'devices paid under a Category I CPT code', 'pathways with a known CMS dollar rate'. Filters: mechanism, CPT category, NTAP status, applicant. Returns pathways with amounts, effective dates, and sourc

• reimbursement_stats

  Distribution of payment mechanisms across the AI/ML reimbursement corpus — pathway and distinct-device counts per mechanism (NTAP, Cat I, Cat III/APC, …) with the min/median/max dollar amounts for each. Deliberately never a single pooled 'reimbursement rate': NTAP add-on amounts

• vehicle_risk_lookup

  Look up NHTSA safety history for a vehicle by make, model, and model year. Returns recall campaigns and complaint statistics (crashes, fires, injuries, top components).

Security scan

• No findings. We scan names, descriptions and tool definitions for hidden instructions and other prompt-injection patterns.

Recent checks