FDA 510(k) Device Clearances · FDA Device Clearances

import { wrapFetchWithPayment } from "@x402/fetch";
import { privateKeyToAccount } from "viem/accounts";

const account = privateKeyToAccount(process.env.PRIVATE_KEY);
const fetchWithPay = wrapFetchWithPayment(fetch, account);

const res = await fetchWithPay("https://x402-filings.datalayer.workers.dev/v1/fda/device-clearances", {
  method: "GET",
});
const data = await res.json();

curl -X GET \
  "https://x402-filings.datalayer.workers.dev/v1/fda/device-clearances?applicant=Medtronic&device=catheter&from=2024-01-01&kNumber=K123456&limit=25&to=2026-08-24" \
  -H "X-PAYMENT: <signed x402 payment>"

{
  "clearances": [
    {
      "applicant": "Example Medical Inc.",
      "decision": "Substantially Equivalent",
      "decisionDate": "2026-08-11",
      "deviceClass": "2",
      "deviceName": "Example Catheter",
      "kNumber": "K260123",
      "reviewedByThirdParty": false
    }
  ],
  "clearancesByYear": [
    {
      "count": 14,
      "year": "2026"
    },
    {
      "count": 11,
      "year": "2025"
    }
  ],
  "count": 25,
  "mostRecentDecision": "2026-08-11",
  "query": {
    "device": "catheter",
    "limit": 25
  },
  "totalMatching": 41233
}