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atlas-fda

io.github.atlasbyauro/atlas-fda
ヘルスケア 法務・コンプライアンス 利用不可 MCP 2026-07-28

このMCPでできること

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

機能

ツール

7 ツール
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.
読み取り専用
入力スキーマ 
{'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.
読み取り専用
入力スキーマ 
{'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.
読み取り専用
入力スキーマ 
{'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.
読み取り専用
入力スキーマ 
{'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.
読み取り専用
入力スキーマ 
{'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.
読み取り専用
入力スキーマ 
{'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.
読み取り専用
入力スキーマ 
{'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'}}}
履歴

最近のツール変更

追加
get_changes
2026年9月17日12:40
追加
search_recalls
2026年9月17日12:40
追加
ai_devices
2026年9月17日12:40
追加
product_code_stats
2026年9月17日12:40
追加
get_clearance
2026年9月17日12:40
追加
find_predicates
2026年9月17日12:40
追加
search_records
2026年9月17日12:40
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