ClearCheck · Device

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://loonie-toll.onrender.com/device", {
  method: "GET",
});
const data = await res.json();

curl -X GET \
  "https://loonie-toll.onrender.com/device?firm=Medtronic" \
  -H "X-PAYMENT: <signed x402 payment>"

{
  "clearances": [
    {
      "advisoryPanel": "Cardiovascular",
      "applicant": "Medtronic, Inc.",
      "clearanceType": "Special",
      "decidedOn": "2026-08-28",
      "decision": "Substantially Equivalent",
      "deviceName": "LINQ II Insertable Cardiac Monitor (ICM) (LNQ22)",
      "kNumber": "K262735",
      "location": "Mounds View, MN, US",
      "productCode": "MXD",
      "receivedOn": "2026-07-31"
    },
    {
      "advisoryPanel": "Cardiovascular",
      "applicant": "Medtronic, Inc.",
      "clearanceType": "Special",
      "decidedOn": "2026-08-21",
      "decision": "Substantially Equivalent",
      "deviceName": "Affera Integrated Mapping System",
      "kNumber": "K262005",
      "location": "Mounds View, MN, US",
      "productCode": "DQK",
      "receivedOn": "2026-06-15"
    }
  ],
  "counts": {
    "clearances": 1585,
    "openRecalls": 8,
    "recalls": 1917
  },
  "disclaimer": "Advisory only, provided as is without warranty of accuracy or completeness. Absence of a 510(k) record is not proof a device is uncleared — exempt and PMA-approved devices are not in this dataset. Not…",
  "query": {
    "device": null,
    "firm": "Medtronic"
  },
  "reasons": [
    "1585 510(k) clearance(s) on record, but 8 recall(s) are still open.",
    "Most recent open recall: Loaner insulin pumps may have been cleaned with chemically incompatible products that could damage the pump case or keypad, allow moisture i"
  ],
  "recalls": [
    {
      "action": "On 7/13/2026, field safety notices were sent to customers asking them to do the following:\n1) Stop using the loaner pump and contact the firm to arrange for loaner pump return. \n2) Contact your Health…",
      "distribution": "International distribution to the countries of Germany, Denmark, Austria, Netherlands, United Kingdom, Italy, Belgium, Ireland, Switzerland, Sweden, Northern Ireland.",
      "initiatedOn": "2026-07-13",
      "postedOn": "2026-08-18",
      "product": "MiniMed 640G Insulin Pump, Model: MMT-1711, MMT-1712;",
      "quantity": "16",
      "reason": "Loaner insulin pumps may have been cleaned with chemically incompatible products that could damage the pump case or keypad, allow moisture ingress, and result in insulin over- or under-delivery, poten…",
      "recallNumber": "Z-2980-2026",
      "recallingFirm": "Medtronic MiniMed, Inc.",
      "relatedClearances": [
        "K251032"
      ],
      "rootCause": "Process design",
      "status": "Open, Classified",
      "terminatedOn": null
    },
    {
      "action": "On 7/13/2026, field safety notices were sent to customers asking them to do the following:\n1) Stop using the loaner pump and contact the firm to arrange for loaner pump return. \n2) Contact your Health…",
      "distribution": "International distribution to the countries of Germany, Denmark, Austria, Netherlands, United Kingdom, Italy, Belgium, Ireland, Switzerland, Sweden, Northern Ireland.",
      "initiatedOn": "2026-07-13",
      "postedOn": "2026-08-18",
      "product": "MiniMed 670G Insulin Pump, Model: MMT-1781, MMT-1782;",
      "quantity": "7",
      "reason": "Loaner insulin pumps may have been cleaned with chemically incompatible products that could damage the pump case or keypad, allow moisture ingress, and result in insulin over- or under-delivery, poten…",
      "recallNumber": "Z-2981-2026",
      "recallingFirm": "Medtronic MiniMed, Inc.",
      "relatedClearances": [],
      "rootCause": "Process design",
      "status": "Open, Classified",
      "terminatedOn": null
    }
  ],
  "retrievedAt": "2026-09-09T00:53:40.644Z",
  "source": "openFDA — 510(k) clearances and device recall enforcement (US FDA)",
  "verdict": "CLEARED_WITH_OPEN_RECALL"
}