atlas-fda
FDA 510(k)s, PMAs, recalls & trials, linked: predicate search and review-time stats for AI agents.
What it can do
What data it sees
Do you need an account
No: the server works without sign-in
FDA 510(k)s, PMAs, recalls & trials, linked: predicate search and review-time stats for AI agents.
How to connect
How to connect atlas-fda to Claude
The server address to paste into Claude settings:
https://atlasbyauro.com/mcp
- Open Claude (claude.ai or the desktop app).
- Go to Settings → Connectors.
- Click Add custom connector.
- Paste the server address copied below into Remote MCP server URL and click Add.
- In a chat, click + → Connectors and switch the new connector on.
Custom connectors are available on Free, Pro, Max, Team and Enterprise plans (Free is limited to one). On Team and Enterprise an organization Owner adds the connector first under Organization settings → Connectors.
Authorization
After you click Add, a sign-in window for the service opens. Sign in with your own account and approve access. Claude never sees your password.
How to connect atlas-fda to ChatGPT
The server address to paste into ChatGPT settings:
https://atlasbyauro.com/mcp
- Open ChatGPT in a browser (chatgpt.com). A Plus, Pro, Business, Enterprise or Edu plan is required.
- Turn on developer mode once: Settings → Apps → Advanced settings → Developer mode.
- Open Settings → Connectors and click Create.
- Fill in the form: Name (anything), Description (one line about what the service does), MCP server URL (copy it below).
- Under Authentication choose OAuth if the service requires sign-in, otherwise None. Click Create.
- In a new chat open + → Apps/Connectors and enable the connector.
OpenAI has renamed this section before (Connectors → Apps/Plugins). If the label differs, search settings for "developer mode". On Business/Enterprise workspaces an admin must allow custom connectors first.
Authorization
On first use ChatGPT opens the service's sign-in window. Sign in and approve access.
How to connect atlas-fda to Cursor
The server address to paste into Cursor settings:
https://atlasbyauro.com/mcp
Fastest: click Open in Cursor below and confirm the prompt.
Manually:
- In Cursor open Settings → Cursor Settings → MCP and click Add new global MCP server.
- Paste the JSON copied below into
~/.cursor/mcp.json(per project:.cursor/mcp.jsonin the repo root). - Save the file. The server appears in the MCP list; authorize it there if asked.
Authorization
If the service needs sign-in, an authorize button appears next to the server in the MCP list.
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. |