Constat — 483 Risk Radar
# Constat — 483 Risk Radar (MCP server)
[](https://glama.ai/mcp/connectors/com.healthai/radar)
<a href="https://glama.ai/mcp/servers/@thehealthai/fda-risk-radar-mcp">
<img width="380" height="200" src="https://glama.ai/mcp/servers/@thehealthai/fda-risk-radar-mcp/badge" alt="Constat 483 Risk Radar MCP server" />
</a>
[](https://mcpqueen.com/s/com.healthai/radar)
The MCP server behind [**Constat**](https://constat.dev) — 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://constat.dev/api/mcp` (legacy `https://radar.healthai.com/api/mcp` still serves)
- **Transport:** Streamable HTTP (JSON-RPC 2.0)
- **Auth:** none for anonymous access (10 work units/min and 50/day per
anonymous source); an optional `X-API-Key` header enables the separately
assigned metered allowance. Tool calls have documented work-unit costs.
- **Registry:** [`com.healthai/radar`](https://registry.modelcontextprotocol.io) (official MCP registry)
The evidence corpus and tool logic run hosted at the endpoint above. This repo
also ships `server.mjs`, a zero-dependency **stdio bridge** to that endpoint, so
stdio-only MCP clients can use the server like any local one:
```bash
node server.mjs # stdio MCP server, bridges to constat.dev/api/mcp
```
```jsonc
// e.g. in an MCP client config
{ "mcpServers": { "constat": { "command": "node", "args": ["/path/to/server.mjs"] } } }
```
```bash
docker build -t constat-mcp . && docker run -i constat-mcp # same, containerized
```
## 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 |
| `firm_compliance_history` | Source-bounded FDA public-record timeline for a device firm — recalls, warning letters, 483s, clearances |
| `watchlist_diff` | Machine-detected FDA public-record changes for monitored product codes since a given date |
| `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
```bash
curl -s https://constat.dev/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).
Each of the 14 tools declares an output schema. Tool calls return structured
content with an explicit `ok`, `not_found`, `invalid_request`, or `unavailable`
status while preserving a text result for older clients.
The tools are observational and non-destructive, but advertise
`readOnlyHint: false` because calls write bounded quota and operational-
telemetry state. They do not publish or modify FDA, CMS, NHTSA, or other
third-party records.
See the [integration guide](https://constat.dev/integrations), [architecture
and trust boundaries](https://constat.dev/architecture), [privacy
notice](https://constat.dev/privacy), and [support page](https://constat.dev/support).
## Related servers
- [Clarity MCP](https://github.com/thehealthai/clarity-mcp) — condition-aware
ingredient, product & supplement safety (verdict + evidence tier + citation).
- [MCP Queen](https://github.com/mcpqueen/mcpqueen) — the graded MCP registry
that independently probes and grades this server.
## About
Built by [Health AI](https://healthai.com), the team behind
[Constat](https://constat.dev). Informational only; verify against primary
FDA/NHTSA sources.
## License
MIT — see [LICENSE](LICENSE).
TDQS
Scored across 14 tools
Each tool has a clearly distinct purpose: device-level premarket/postmarket lookups, firm compliance history, search across evidence/postmarket/reimbursement, statistical aggregates, predicate tracing, watchlist diff, and even a vehicle safety lookup. The detailed descriptions further minimize ambiguity.
Tool names follow a consistent pattern: domain prefix (device_, firm_, evidence_, etc.) plus operation suffix (lookup, search, stats, diff, chain). All snake_case. The sole outlier vehicle_risk_lookup still follows the same pattern, maintaining overall consistency.
14 tools is on the higher end of the ideal range (3-15) but each tool serves a specific, non-redundant purpose within the regulatory intelligence domain. The count is reasonable given the breadth of covered areas (premarket, postmarket, reimbursement, and vehicle safety).
The tool set covers the key aspects of medical device regulatory intelligence: premarket evidence, postmarket surveillance, reimbursement, firm compliance, and trend monitoring. However, the inclusion of vehicle_risk_lookup (NHTSA) is a slight domain mismatch, and there is no tool for listing or searching product codes/panels directly, though these are used as filters elsewhere.