FDA data for AI/ML medical devices: 510(k) evidence, predicate chains, recalls, reimbursement.
FDA data for AI/ML medical devices: 510(k) evidence, predicate chains, recalls, reimbursement.
Constat — 483 Risk Radar (FDA/NHTSA) · v0.4.4 (latest)
by Healthai.com
Constat — 483 Risk Radar (MCP server)
The MCP server behind Constat — FDA & NHTSA regulatory-risk intelligence for AI agents, over the Model Context Protocol. Live public regulatory data — recalls, adverse events, warning letters, 510(k) premarket evidence, postmarket drift signals, reimbursement pathways, and vehicle safety. Decision support, not regulatory advice.
- Endpoint:
https://radar.healthai.com/api/mcp - Transport: Streamable HTTP (JSON-RPC 2.0)
- Auth: none for the free tier (60 req/min per IP; an optional
X-API-Keyheader raises limits — shared with Clarity MCP, request one atPOST https://mcp.healthai.com/register) - Registry:
com.healthai/radar(official MCP registry)
This repository is the public listing/reference for the hosted 483 Risk Radar MCP server. The server itself runs at the endpoint above; this repo carries the
server.jsonmanifest and.well-known/mcp.jsondiscovery document for registries and crawlers.
Tools
| Tool | What it does |
|---|---|
device_risk_lookup |
FDA compliance risk for a device category by 3-letter product code — recalls, MAUDE trend, warning-letter matches, composite score |
device_evidence_lookup |
Parsed 510(k) premarket evidence for an AI/ML device, each field with a verbatim source quote + page |
evidence_search |
Find AI/ML clearances by product code, panel, applicant, clinical data, sensitivity metric, or PCCP |
predicate_chain |
Trace a device's predicate ancestry with each predicate's age at clearance |
evidence_cohort_stats |
Reporting-rate stats across the parsed AI/ML corpus — presence figures with denominators |
device_postmarket_lookup |
Post-clearance intelligence for one device — recalls, MAUDE trend, letter/483 matches, drift signals |
postmarket_search |
Find devices by postmarket criteria — drift signals, recalls in 24mo, rising MAUDE trend |
cohort_postmarket_stats |
Postmarket presence rates across the AI/ML cohort, each with its denominator |
reimbursement_lookup |
Clearance-to-payment pathway by K/DEN or CPT code — NTAP, Cat I/III, CMS rates, HCPCS, LCDs |
reimbursement_search |
Find payment pathways by mechanism, CPT category, NTAP status, applicant |
reimbursement_stats |
Mechanism distribution across the reimbursement corpus with dollar ranges |
vehicle_risk_lookup |
NHTSA safety history by make/model/year — recall campaigns and complaint stats |
Quick start
curl -s https://radar.healthai.com/api/mcp \
-H 'content-type: application/json' \
-H 'accept: application/json, text/event-stream' \
-d '{"jsonrpc":"2.0","id":1,"method":"tools/call",
"params":{"name":"device_risk_lookup","arguments":{"product_code":"FRN"}}}'
List tools with {"method":"tools/list"}. Note the Accept header must include
text/event-stream (streamable-HTTP requirement).
Related servers
- Clarity MCP — condition-aware ingredient, product & supplement safety (verdict + evidence tier + citation).
- MCP Queen — the graded MCP registry that independently probes and grades this server.
About
Built by Health AI, the team behind Constat. Informational only; verify against primary FDA/NHTSA sources.
License
MIT — see LICENSE.