atlas-fda
Server Details
FDA 510(k)s, PMAs, recalls & trials, linked: predicate search and review-time stats for AI agents.
- Status
- Healthy
- Last Tested
- Transport
- Streamable HTTP
- URL
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Usage analytics
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Tool Definition Quality
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Available Tools
5 toolsfind_predicatesInspect
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.
| Name | Required | Description | Default |
|---|---|---|---|
| limit | No | Max candidates (default 15, max 40) | |
| product_code | Yes | Three-letter FDA product code, e.g. NBW |
get_changesInspect
New FDA clearances and recalls since a date - the monitoring feed. Use for 'what changed this week' questions.
| Name | Required | Description | Default |
|---|---|---|---|
| kind | No | ||
| since | Yes | ISO date, e.g. 2026-08-01 |
get_clearanceInspect
Full detail for one FDA 510(k) clearance by K-number, including recalls that reference it.
| Name | Required | Description | Default |
|---|---|---|---|
| k_number | Yes | e.g. K262116 |
product_code_statsInspect
FDA review-time statistics (median and 90th percentile days to decision), clearance count and recall count for a product code.
| Name | Required | Description | Default |
|---|---|---|---|
| product_code | Yes |
search_recordsInspect
Full-text search across 777k+ FDA 510(k) clearances, device recalls, and registered clinical trials. Returns ranked matches with links.
| Name | Required | Description | Default |
|---|---|---|---|
| kind | No | Optional: restrict to one record type | |
| query | Yes | Device name, manufacturer, sponsor, condition, or identifier |
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{
"$schema": "https://glama.ai/mcp/schemas/connector.json",
"maintainers": [{ "email": "your-email@example.com" }]
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