Give your AI assistant the FDA record

Atlas is a Model Context Protocol (MCP) server - the first in regulatory data. Connect it once and Claude, ChatGPT or any MCP-compatible agent can search clearances, find predicate candidates, pull review-time statistics and monitor recalls, natively, with citations back to the source pages.

Connect it

Add a custom connector / MCP server with this URL (get a free key in one click - 1,000 calls/month):

https://atlasbyauro.com/mcp?key=YOUR_KEY

Get a free key Transport: Streamable HTTP, stateless. Works in Claude (Settings → Connectors), ChatGPT (developer mode), Cursor, and any MCP client.

What your agent can do

Tool	What it answers
`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.
`get_changes`	New FDA clearances and recalls since a date - the monitoring feed. Use for 'what changed this week' questions.

Try asking your assistant

"Find predicate candidates for product code NBW"

Calls find_predicates - returns recent clearances under the code with review times and recall indicators, each linked to its Atlas page.

"How long does FDA take to clear blood glucose monitors?"

Calls product_code_stats - median and 90th-percentile days-to-decision computed from the record.

"What cleared in cardiology this week?"

Calls get_changes - the monitoring feed, fresh after every weekly refresh.

Metering

Each tool call counts as one API request against your key's plan - free 1,000/mo, Pro 50,000/mo ($29), Business 500,000/mo ($149). Same key works for the REST API. Pricing.

For registry crawlers

Machine-readable: /.well-known/mcp.json · /llms.txt · server.json in our repository.