Constat MCP — FDA Device Evidence Lifecycle MCP Server

by healthai Your server? Claim it

answering

Constat MCP — FDA Device Evidence Lifecycle is answering right now. Last checked 1 min ago. It exposes 14 tools.

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

The linked repository no longer exists on GitHub — it was deleted or made private.

Uptime history 47 days of history

47 days agonow

100.0%

Uptime 24h

92 of 92 checks

Tools

read from the server

374 ms

Response time

average over 24h

open, no key

Access

streamable-http

What changed 10

Every tool that appeared, vanished or quietly changed what it asks for. Recorded since 9 August 2026. No other catalogue keeps this.

30 Aug a tool description was rewritten evidence_search

9 Aug 9 tools changed the parameters they ask for cohort_postmarket_stats, device_risk_lookup, evidence_cohort_stats and 6 more

This one has been quiet for a while

Quiet is not dead — but it is worth knowing when it wakes up, or when someone else takes it over. We watch the repository and tell you either way.

Connect this server

Endpoint below is the one we actually reach during checks — not the one copied from a README. Last verified 1 min ago.

Claude Code Claude Desktop Codex Cursor VS Code

run in your terminal

claude mcp add radar --transport http https://constat.dev/api/mcp

~/Library/Application Support/Claude/claude_desktop_config.json

{
  "mcpServers": {
    "radar": {
      "url": "https://constat.dev/api/mcp"
    }
  }
}

~/.codex/config.toml

[mcp_servers.radar]
url = "https://constat.dev/api/mcp"

.cursor/mcp.json

{
  "mcpServers": {
    "radar": {
      "url": "https://constat.dev/api/mcp"
    }
  }
}

.vscode/mcp.json

{
  "mcpServers": {
    "radar": {
      "url": "https://constat.dev/api/mcp"
    }
  }
}

Available tools 14

Read directly from the server with tools/list, grouped by what they act on. If a tool disappears, we record the date.

device

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 means the summary did not state it.

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 patterns, predicate-cohort recall activity). Descriptive observables with sources — never a safety judgment.

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 against a firm.

reimbursement

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/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.

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 reimbursement_stats for the mechanism distribution (never a single pooled reimbursement rate).

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 different measurements and are reported separately with their own spreads.

evidence

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. Predicate age (median years between a clearance and its cited predicates) is included when decision-date coverage clears a 60% floor, and withheld otherwise.

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's K-number for the full source-quoted FDA record. Presence flags are descriptive: 'reports a sensitivity metric' is not 'reports a comparable sensitivity' — analysis units differ across devices.

cohort

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.

firm

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.

postmarket

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.

predicate

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.

vehicle

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).

watchlist

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 status are excluded; use next_since as the next polling cursor.

Endpoints

URL	Transport	State	Latency	Checked
https://constat.dev/api/mcp	streamable-http	answering	301 ms	1 min ago

Alternatives to Constat MCP — FDA Device Evidence Lifecycle

same job, measured the same way

Mdr Medical Device MCP

by csoai-org

EU MDR (Reg 2017/745) and IVDR (Reg 2017/746) compliance for medical device + IVD manufacturers...

164 installs/wk local only

Compliance

by rulemesh

Engineered GDPR compliance for engineers and AI agents: pull rules, implement, submit evidence.

answering

Tork Governance

by torkjacobs

AI agent governance for MCP: PII detection, policy enforcement, compliance, and kill switch.

45 installs/wk local only

Agent Decision & Evidence Tools (MCP + x402)

by patrickpi1312

40 MCP tools: multi-chain RPC, market and transaction decisions, AI, EU compliance and US imports

40 tools answering

EU Audit Trail

by jellewas

Tamper-evident audit trail MCP server for EU AI Act & GDPR compliance.

72 installs/wk local only

Avalara E-Invoicing & Live Reporting

by avalara

Provides access to Avalara E-Invoicing and Live Reporting APIs for document statuses and compliance

answering

Raportagent MCP

by raportagent

Sourced market and compliance research for Claude Desktop, Claude Code and Cursor.

29 installs/wk local only

OntoRamp Governance Assessment

by ontoramp

Governance maturity assessment, compliance gap analysis, and evidence-linked briefs for AI agents.

answering

Constat MCP — FDA Device Evidence Lifecycle — questions

Answers built from our own checks of this server.

What can Constat MCP — FDA Device Evidence Lifecycle do?

It exposes 14 tools, read directly from the server on our last check. Among them: cohort_postmarket_stats, device_evidence_lookup, device_postmarket_lookup, device_risk_lookup, evidence_cohort_stats, evidence_search and 8 more. The full list with descriptions is on this page — we take it from the server itself via tools/list, not from a README. How MCP servers expose tools in the first place →

What is Constat MCP — FDA Device Evidence Lifecycle mostly used for?

Its tools cluster around reimbursement, device and evidence. That is what this server is built to work with — the grouping comes from the actual tool names, not from a category we assigned.

Is Constat MCP — FDA Device Evidence Lifecycle working right now?

We send a real MCP handshake every 15 minutes. Over the last 24 hours 92 of 92 checks got a reply (100.0%), average response time 374 ms. The bar chart above shows every period we have measured.

Is Constat MCP — FDA Device Evidence Lifecycle still maintained?

The linked repository no longer exists on GitHub — it was deleted or made private. We show this because it changes what you can expect: an unmaintained server may keep answering for months and then stop without warning.

How do I connect Constat MCP — FDA Device Evidence Lifecycle?

Copy the ready config from this page — we generate it for Claude Code, Claude Desktop, Codex, Cursor and VS Code, each with the file path that client actually reads. It is a remote server, so there is nothing to install — the client connects to the address.

Does Constat MCP — FDA Device Evidence Lifecycle need an API key?

No. Constat MCP — FDA Device Evidence Lifecycle completed a full MCP handshake with us as an anonymous client and listed its tools without asking for anything. All 14 of them are readable on this page. This is what we observed, not what the docs claim.

How fast is Constat MCP — FDA Device Evidence Lifecycle?

It answers our handshake in 374 ms on average, which is faster than 41% of all working MCP servers we measure. The comparison comes from our own checks across the whole registry, every 15 minutes.