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X402 · Fda 510k

Search FDA 510(k) clearances by device name or applicant (manufacturer). Returns K-number, decision date, product code, decision description, and link to FDA summary. Pay 0.001 USDC on Base.

GET https://mcp-x402.onrender.com/x402/fda-510k

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{
  "device": "pulse oximeter",
  "applicant": "Medtronic",
  "limit": 10
}

{
  "source": "openFDA device/510k",
  "query": {
    "device": "oximeter",
    "applicant": null,
    "search": "device_name:oximeter"
  },
  "total_found": 434,
  "returned": 10,
  "clearances": [
    {
      "k_number": "K252655",
      "device_name": "Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, P",
      "applicant": "Shenzhen Imdk Medical Technology Co., Ltd.",
      "decision_date": "2026-05-11",
      "decision": "Substantially Equivalent",
      "product_code": "DQA",
      "summary_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252655"
    },
    {
      "k_number": "K252448",
      "device_name": "AViTA Pulse Oximeter (SP61)",
      "applicant": "Avita Corporation",
      "decision_date": "2026-02-27",
      "decision": "Substantially Equivalent",
      "product_code": "DQA",
      "summary_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252448"
    }
  ],
  "_disclaimer": "510(k) clearance means FDA found substantial equivalence to a predicate device —"
}