MCP Radar
MCP Server

atlas-fda

io.github.atlasbyauro/atlas-fda
Healthcare Legal & Compliance Unavailable MCP 2026-07-28

What this MCP does

Searches and analyzes FDA medical-device clearances, recalls, clinical trials, predicate candidates, and review-time statistics.

Capabilities

Tools

7 tools
ai_devices
FDA AI-enabled device list
FDA's official Artificial Intelligence-Enabled Medical Devices list (1,500+ authorizations), tracked weekly by Atlas. List recent AI device authorizations, filter by panel or year, or check whether a specific submission number is on the list. openFDA itself has no AI field - this is the joined, queryable version.
Read only
Input schema 
{'type': 'object', 'properties': {'year': {'type': 'string', 'description': 'Filter by decision year, e.g. 2025'}, 'limit': {'type': 'number', 'description': 'Max results (default 15, max 40)'}, 'panel': {'type': 'string', 'description': 'Filter by lead panel, e.g. Radiology, Cardiovascular'}, 'submission_number': {'type': 'string', 'description': 'Check one submission, e.g. K254207 or DEN200001'}}}
find_predicates
Find predicate candidates
List predicate device candidates for a 510(k) submission: recent clearances under an FDA product code, with review times and recall indicators. The starting set for predicate research.
Read only
Input schema 
{'type': 'object', 'required': ['product_code'], 'properties': {'limit': {'type': 'number', 'description': 'Max candidates (default 15, max 40)'}, 'product_code': {'type': 'string', 'description': 'Three-letter FDA product code, e.g. NBW'}}}
get_changes
What changed this week
New FDA clearances and recalls since a date - the monitoring feed. Use for 'what changed this week' questions.
Read only
Input schema 
{'type': 'object', 'required': ['since'], 'properties': {'kind': {'enum': ['clearance', 'recall'], 'type': 'string'}, 'since': {'type': 'string', 'description': 'ISO date, e.g. 2026-08-01'}}}
get_clearance
Get a 510(k) clearance
Full detail for one FDA 510(k) clearance by K-number, including recalls that reference it.
Read only
Input schema 
{'type': 'object', 'required': ['k_number'], 'properties': {'k_number': {'type': 'string', 'description': 'e.g. K262116'}}}
product_code_stats
FDA review-time statistics
FDA review-time statistics (median and 90th percentile days to decision), clearance count and recall count for a product code.
Read only
Input schema 
{'type': 'object', 'required': ['product_code'], 'properties': {'product_code': {'type': 'string'}}}
search_recalls
Search device recalls
Search FDA device recalls by product code, recalling firm, or free text. Returns recall details with links - use to vet a predicate candidate or monitor a market.
Read only
Input schema 
{'type': 'object', 'properties': {'firm': {'type': 'string', 'description': 'Recalling firm name (substring match)'}, 'limit': {'type': 'number', 'description': 'Max results (default 15, max 40)'}, 'query': {'type': 'string', 'description': 'Free text matched against the recall description'}, 'product_code': {'type': 'string', 'description': 'Three-letter FDA product code, e.g. NBW'}}}
search_records
Search the FDA record
Full-text search across 777k+ FDA 510(k) clearances, device recalls, and registered clinical trials. Returns ranked matches with links.
Read only
Input schema 
{'type': 'object', 'required': ['query'], 'properties': {'kind': {'enum': ['clearance', 'recall', 'trial', 'warning-letter', 'denovo'], 'type': 'string', 'description': 'Optional: restrict to one record type'}, 'query': {'type': 'string', 'description': 'Device name, manufacturer, sponsor, condition, or identifier'}}}
History

Recent tool changes

Added
get_changes
Sept. 17, 2026, 12:40 p.m.
Added
search_recalls
Sept. 17, 2026, 12:40 p.m.
Added
ai_devices
Sept. 17, 2026, 12:40 p.m.
Added
product_code_stats
Sept. 17, 2026, 12:40 p.m.
Added
get_clearance
Sept. 17, 2026, 12:40 p.m.
Added
find_predicates
Sept. 17, 2026, 12:40 p.m.
Added
search_records
Sept. 17, 2026, 12:40 p.m.
Discover

Similar MCP servers

mcp

com.medigami/mcp

Analyzes medical bills and insurance denials, estimates healthcare costs, identifies assistance options, and supports appeals and…

Medicare Coverage

io.github.pipeworx-io/medicare-coverage

Provides structured Medicare coverage documents, policy timelines, utilization, enrollment, supplier, and payment-related data fr…

Fda Drug Competition

io.github.pipeworx-io/fda-drug-competition

Analyzes FDA Orange Book drug applications, patents, exclusivities, generic competition, and loss-of-exclusivity timelines.

FDA Data MCP

io.github.medley/fda-data

Searches and analyzes FDA data covering drugs, devices, facilities, inspections, recalls, approvals, shortages, enforcement, and …

Cms Open Payments

io.github.pipeworx-io/cms-open-payments

Searches and analyzes CMS Open Payments data on payments from pharmaceutical and device companies to physicians, hospitals, and o…

Dailymed

io.github.pipeworx-io/dailymed

Retrieves FDA DailyMed structured drug labels, label histories and diffs, drug classes, recent updates, and label references by d…

Codex Gsfa

io.github.pipeworx-io/codex-gsfa

Queries Codex GSFA food-additive regulations, including permitted additives, food categories, maximum use levels, qualifying note…

Sfda Drugs

io.github.pipeworx-io/sfda-drugs

Provides Saudi Food and Drug Authority drug records and related regulatory and market research access.