atlas-fda
FDA 510(k)s, PMAs, recalls & trials, linked: predicate search and review-time stats for AI agents.
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What it can do
What data it sees
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FDA 510(k)s, PMAs, recalls & trials, linked: predicate search and review-time stats for AI agents.
Server tool list (7)
Raw names from tools/list. Only developers need these.
| search_records | Full-text search across 777k+ FDA 510(k) clearances, device recalls, and registered clinical trials. Returns ranked matches with links. |
| find_predicates | 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. |
| get_clearance | Full detail for one FDA 510(k) clearance by K-number, including recalls that reference it. |
| product_code_stats | FDA review-time statistics (median and 90th percentile days to decision), clearance count and recall count for a product code. |
| ai_devices | 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. |
| search_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. |
| get_changes | New FDA clearances and recalls since a date - the monitoring feed. Use for 'what changed this week' questions. |