FDA 510(k) device clearances

Search FDA 510(k) premarket clearances (openFDA) by applicant, three-letter product code, K number or device name: decision and date, clearance type, device class, regulation number, the FDA classification name, medical specialty, and a link to the FDA record. Send GET /api/device-510k with no required fields (5 optional) and pay $0.004 per call over x402 or MPP (there is no free tier). It returns a JSON object with query, count, clearances, returned, matched and 4 more.

Newest decision first; the answer says how many clearances matched. Live FDA data, no key.

Try in playground →

Parameters

Example request

curl -i "https://agent402.tools/api/device-510k?applicant=medtronic&limit=5"

Without payment this returns HTTP 402 Payment Required with the exact price for device-510k; any x402 v2 or MPP client pays it and retries.

Example response

{
  "query": {
    "applicant": "medtronic",
    "productCode": null,
    "kNumber": null,
    "deviceName": null
  },
  "count": 1,
  "clearances": [
    {
      "kNumber": "K251234",
      "applicant": "Medtronic, Inc.",
      "deviceName": "Example Device",
      "productCode": "FGE",
      "classificationName": "Stents, Drains And Dilators For The Biliary Ducts",
      "deviceClass": "2",
      "regulationNumber": "876.5010",
      "medicalSpecialty": "Gastroenterology, Urology",
      "decisionDate": "2026-09-30",
      "decision": "Substantially Equivalent",
      "decisionCode": "SESE",
      "dateReceived": "2026-06-02",
      "clearanceType": "Traditional",
      "statementOrSummary": "Summary",
      "thirdPartyReview": false,
      "applicantCity": "Plymouth",
      "applicantState": "MN",
      "applicantCountry": "US",
      "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251234"
    }
  ],
  "returned": 1,
  "matched": 1587,
  "complete": false,
  "truncated": true,
  "disclaimer": "openFDA data is unvalidated and is not medical advice; do not rely on it to make decisions regarding medical care.",
  "source": "api.fda.gov (openFDA device 510(k), public domain)"
}

From an MCP client

catalog.call {
  "slug": "device-510k",
  "params": {
    "applicant": "medtronic",
    "limit": 5
  }
}

The hosted connector at https://agent402.tools/mcp needs a payment for device-510k; the stdio package pays it from a wallet or from an AGENT402_CREDITS_KEY issued earlier. Local install: npx -y agent402-mcp.

Errors and behavior

• Every field is optional. An input the tool rejects returns an HTTP 4xx whose body carries error, tool, expected, required and example.
• A paid call that ends in any status of 400 or above is not charged over x402, MPP or a prepaid credits key: settlement is cancelled when the tool fails. The exception is a Tempo push credential, a transfer the buyer sent before the call: it settles before the tool runs, so if the tool then fails the payment is recorded as a refund owed to the paying wallet.
• Wallet-only: this tool reaches the network or stored state, so it has no proof-of-work tier. A prepaid card-credits key issued earlier (Authorization: Bearer a402_...) also pays it.
• A POST with a JSON body to /api/device-510k is served as this GET, with the body as the input.
• An Idempotency-Key header makes a retried paid call replay the first 200 instead of charging again (an answer larger than 1 MB is not replayed).

Paid call (JavaScript agent)

import { wrapFetchWithPayment } from "@x402/fetch";
import { x402Client } from "@x402/core/client";
import { registerExactEvmScheme } from "@x402/evm/exact/client";
import { privateKeyToAccount } from "viem/accounts";

const client = new x402Client();
client.setSpendControls?.({ maxAmountPerPayment: "$0.004" }); // refuse any quote above this tool's price
registerExactEvmScheme(client, { signer: privateKeyToAccount(KEY) });
const payFetch = wrapFetchWithPayment(fetch, client);

const res = await payFetch("https://agent402.tools/api/device-510k?applicant=medtronic&limit=5");

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