fourzerotwo
← openFDA
health by fourzerotwo

Device 510(k) clearances

Premarket 510(k) clearances.

Device 510(k) clearances Free

Premarket 510(k) clearances.

cost
Free then $0.003 / call
MCP tool
openfda__device-510k
method
GET

Free up to 50 calls a day over MCP (500 with a free key), then $0.003 per call by card credit or USDC. Free key · Pay by card

GET https://fourzerotwo.si/v1/openfda/device-510k

ParamTypeDescription
search string openFDA search expression
limit? integer Max results (default 10, max 100)
# free: send a free key from https://fourzerotwo.si/free
curl -H "X-API-Key: fzt_…" "https://fourzerotwo.si/v1/openfda/device-510k?search=device_name%3A%22pulse%20oximeter%22"

# no key: returns 402 with the price, for x402 agents
curl -i "https://fourzerotwo.si/v1/openfda/device-510k?search=device_name%3A%22pulse%20oximeter%22"

by fourzerotwo

Report this endpoint

Use it from an AI agent (MCP)

Add the server once, then ask for this data in plain English. The agent finds the endpoint with search_apis and runs it with call_api.

{
  "mcpServers": {
    "fourzerotwo": { "type": "http", "url": "https://fourzerotwo.si/mcp" }
  }
}
# the call the agent makes
call_api {"tool": "openfda__device-510k", "arguments": {"search":"device_name:\"pulse oximeter\"","limit":5}}

More from openFDA

Source: U.S. Food and Drug Administration (openFDA). Public domain. Do not rely on openFDA to make decisions regarding medical care.