# Constat MCP — FDA Device Evidence Lifecycle MCP server

FDA and CMS evidence for AI medical devices: 510(k), postmarket, reimbursement, and compliance.

## Links
- Registry page: https://www.getdrio.com/mcp/com-healthai-radar
- Repository: https://github.com/healthai-hq/fda-risk-radar
- Website: https://constat.dev/connect

## Install
- Endpoint: https://constat.dev/api/mcp
- Auth: Not captured

## Setup notes
- Remote endpoint: https://constat.dev/api/mcp

## Tools
- device_risk_lookup (Review Device Category Risk Signals) - 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 predict enforcement against a firm. Endpoint: https://constat.dev/api/mcp
- firm_compliance_history (Review 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 attribution and coverage limits with the records; it is not a finding of noncompliance or a prediction of FDA action. Endpoint: https://constat.dev/api/mcp
- watchlist_diff (Poll Watchlist Changes) - 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 and internal review status are excluded; use next_since as the next polling cursor. Endpoint: https://constat.dev/api/mcp
- device_evidence_lookup (Look Up Device Evidence) - 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 quote and page. Null means the summary did not state it. Endpoint: https://constat.dev/api/mcp
- evidence_search (Search Device Evidence) - 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 matching records with their parsed evidence. Presence flags are descriptive: 'reports a sensitivity metric' is not 'reports a comparable sensitivity' — analysis units differ across devices. Endpoint: https://constat.dev/api/mcp
- predicate_chain (Trace 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. Endpoint: https://constat.dev/api/mcp
- evidence_cohort_stats (Summarize Evidence Cohort) - 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 queue separately. Predicate age (median years between a clearance and its cited predicates) is included when decision-date coverage clears a 60% floor, and withheld otherwise. Endpoint: https://constat.dev/api/mcp
- device_postmarket_lookup (Look Up Device Postmarket Signals) - 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, software-recall patterns, predicate-cohort recall activity). Descriptive observables with sources — never a safety judgment. Endpoint: https://constat.dev/api/mcp
- postmarket_search (Search Postmarket Signals) - 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. Endpoint: https://constat.dev/api/mcp
- cohort_postmarket_stats (Summarize Postmarket Cohort) - 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. Endpoint: https://constat.dev/api/mcp
- reimbursement_lookup (Look Up Reimbursement Pathways) - 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, plus any commercial/MAC payer coverage policies that reference the clearance or its codes. Answers 'who got paid, how much, through which mechanism, on what basis.' CPT codes are bare factual identifiers only — no procedure descriptors; follow the CMS source link for the official descriptor. Endpoint: https://constat.dev/api/mcp
- reimbursement_search (Search Reimbursement Pathways) - 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 sources. Use reimbursement_stats for the mechanism distribution (never a single pooled reimbursement rate). Endpoint: https://constat.dev/api/mcp
- reimbursement_stats (Summarize Reimbursement Cohort) - 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 and CMS rates are different measurements and are reported separately with their own spreads. Endpoint: https://constat.dev/api/mcp
- vehicle_risk_lookup (Look Up Vehicle Safety History) - 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). Endpoint: https://constat.dev/api/mcp

## Resources
Not captured

## Prompts
Not captured

## Metadata
- Owner: com.healthai
- Version: 0.5.3
- Runtime: Streamable Http
- Transports: HTTP
- License: Not captured
- Language: Not captured
- Stars: Not captured
- Updated: Jul 30, 2026
- Source: https://registry.modelcontextprotocol.io