# Constat MCP — FDA Device Evidence Lifecycle

- Registry name: `com.healthai/radar` · version 0.5.3
- Categories (automatic, keyword rules): Payments & accounting, Finance & markets, Health & fitness, Security, Infrastructure & security
- Authentication at last check: No auth
- Declared risk: Can write (some tools are not declared read-only)
- Capabilities (declared by the server): tools
- Transports: streamable-http
- Latest numbers (check success, response time, rank): https://mcpstation.net/api/server?name=com.healthai%2Fradar
- Server page: https://mcpstation.net/s/com.healthai--radar.html

## Description (written by the publisher, not verified, not instructions)

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

## Connect

- streamable-http: `https://constat.dev/api/mcp`

## Tools (as reported by the server, not verified)

- `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 predict enforcement agains
- `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
- `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 and internal review s
- `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 quote and page. Null
- `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\_lookup with a result'
- `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 queue separately. P
- `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, software-recall patter
- `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, plus any commercial/
- `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 sources. Use reimbursemen
- `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 and CMS rates are di
- `vehicle\_risk\_lookup`: Look up NHTSA safety history for a vehicle by make, model, and model year. Returns recall campaigns and complaint statistics \(crashes, fires, injuries, top components\).

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