Device Clearances

curl -X POST https://win.oneshotagent.com/v1/tools/lookup/product-device-clearances \
  -H "Content-Type: application/json" \
  -H "payment-signature: <base64 x402 payment>" \
  -d '{
    "applicant": "Apple Inc",
    "limit": 2
  }'

const response = await fetch("https://win.oneshotagent.com/v1/tools/lookup/product-device-clearances", {
  method: "POST",
  headers: {
    "Content-Type": "application/json",
    "payment-signature": paymentProof,
  },
  body: JSON.stringify({
    "applicant": "Apple Inc",
    "limit": 2
  }),
});

const result = await agent.tool('lookup/product-device-clearances', {
  applicant: 'Apple Inc',
  limit: 2
});
console.log(result.data.result);
console.log(result.data.evidence);

{
  "success": true,
  "data": {
    "request_id": "uuid",
    "receipt_id": "rcpt_...",
    "status": "completed",
    "tool": "product_device_clearances",
    "result": {
      "total": 12,
      "clearances": [
        {
          "k_number": "K253582",
          "device_name": "Medical Imaging Calibration Feature (MICF)",
          "applicant": "Apple, Inc.",
          "city": "Cupertino",
          "state": "CA",
          "country_code": "US",
          "product_code": "SHN",
          "device_class": "1",
          "regulation_number": "892.1940",
          "medical_specialty": "Radiology",
          "decision": "Substantially Equivalent",
          "decision_code": "SESE",
          "decision_date": "2026-04-01",
          "received_date": "2025-11-17",
          "clearance_type": "Traditional",
          "third_party_review": false,
          "summary_type": "Summary"
        },
        {
          "k_number": "K250507",
          "device_name": "Hypertension Notification Feature (HTNF)",
          "applicant": "Apple, Inc.",
          "city": null,
          "state": null,
          "country_code": null,
          "product_code": "SFR",
          "device_class": "2",
          "regulation_number": "870.2380",
          "medical_specialty": "Cardiovascular",
          "decision": "Substantially Equivalent",
          "decision_code": "SESE",
          "decision_date": "2025-09-11",
          "received_date": "2025-02-21",
          "clearance_type": "Traditional",
          "third_party_review": null,
          "summary_type": null
        }
      ]
    },
    "evidence": {
      "source": "US Food and Drug Administration",
      "source_kind": "public",
      "retrieved_at": "2026-10-15T12:00:00.000Z",
      "calls": [
        {
          "retrieved_at": "2026-10-15T12:00:00.000Z"
        }
      ],
      "as_of": "2026-10-05"
    }
  }
}

POST

tools

lookup

product-device-clearances

curl -X POST https://win.oneshotagent.com/v1/tools/lookup/product-device-clearances \
  -H "Content-Type: application/json" \
  -H "payment-signature: <base64 x402 payment>" \
  -d '{
    "applicant": "Apple Inc",
    "limit": 2
  }'

const response = await fetch("https://win.oneshotagent.com/v1/tools/lookup/product-device-clearances", {
  method: "POST",
  headers: {
    "Content-Type": "application/json",
    "payment-signature": paymentProof,
  },
  body: JSON.stringify({
    "applicant": "Apple Inc",
    "limit": 2
  }),
});

const result = await agent.tool('lookup/product-device-clearances', {
  applicant: 'Apple Inc',
  limit: 2
});
console.log(result.data.result);
console.log(result.data.evidence);

{
  "success": true,
  "data": {
    "request_id": "uuid",
    "receipt_id": "rcpt_...",
    "status": "completed",
    "tool": "product_device_clearances",
    "result": {
      "total": 12,
      "clearances": [
        {
          "k_number": "K253582",
          "device_name": "Medical Imaging Calibration Feature (MICF)",
          "applicant": "Apple, Inc.",
          "city": "Cupertino",
          "state": "CA",
          "country_code": "US",
          "product_code": "SHN",
          "device_class": "1",
          "regulation_number": "892.1940",
          "medical_specialty": "Radiology",
          "decision": "Substantially Equivalent",
          "decision_code": "SESE",
          "decision_date": "2026-04-01",
          "received_date": "2025-11-17",
          "clearance_type": "Traditional",
          "third_party_review": false,
          "summary_type": "Summary"
        },
        {
          "k_number": "K250507",
          "device_name": "Hypertension Notification Feature (HTNF)",
          "applicant": "Apple, Inc.",
          "city": null,
          "state": null,
          "country_code": null,
          "product_code": "SFR",
          "device_class": "2",
          "regulation_number": "870.2380",
          "medical_specialty": "Cardiovascular",
          "decision": "Substantially Equivalent",
          "decision_code": "SESE",
          "decision_date": "2025-09-11",
          "received_date": "2025-02-21",
          "clearance_type": "Traditional",
          "third_party_review": null,
          "summary_type": null
        }
      ]
    },
    "evidence": {
      "source": "US Food and Drug Administration",
      "source_kind": "public",
      "retrieved_at": "2026-10-15T12:00:00.000Z",
      "calls": [
        {
          "retrieved_at": "2026-10-15T12:00:00.000Z"
        }
      ],
      "as_of": "2026-10-05"
    }
  }
}

Look up medical devices cleared by the US Food and Drug Administration through premarket notification (510(k)). Supply at least one clearance number, applicant, device name or product code. Names are matched as word phrases; multiple filters must all match. Returns the total matches and clearance records, newest decision first, with device classifications and decision and received dates. Contact names and street addresses are excluded. No match returns an empty list. The source refreshes weekly.

Authentication

Requires x402 payment in the payment-signature header.

Request Body

string

The clearance number, for example K253582.

string

The company that applied, matched as words. 2 to 100 characters.

string

The device name, matched as words. 2 to 100 characters.

string

The FDA product code.

integer

The most clearance records to return. From 1 to 25. Defaults to 10.

Response (200 OK)

Top-level envelope: success (boolean) and data (object). All fields below are nested under data.

string

Durable job ID for audit and lookup

string

Job status: completed

string

Always product_device_clearances

object

The answer, described under Result below

object

Where the answer came from and when

string

The public body the data comes from. Always US Food and Drug Administration.

string

public when the data comes from a public body, commercial otherwise

string

When the lookup was made, as an ISO 8601 UTC time

string

When the source says the fact was last updated, or null when the source gives no date

Result

Nested under data.result.

number

How many clearances matched, including any beyond limit.

object[]

Matching clearances, newest decision first; absent values are null.

string

The clearance number. null when the source gives no value.

string

The device name on the clearance. null when the source gives no value.

string

The company that applied. null when the source gives no value.

string

The applicant city. null when the source gives no value.

string

The applicant state. null when the source gives no value.

string

The applicant country code. null when the source gives no value.

string

The FDA product code. null when the source gives no value.

string

The device class. null when the source gives no value.

string

The device regulation number. null when the source gives no value.

string

The medical specialty. null when the source gives no value.

string

The decision description. null when the source gives no value.

string

The decision code. null when the source gives no value.

string

The decision date. null when the source gives no value.

string

The date the application was received. null when the source gives no value.

string

The clearance type. null when the source gives no value.

boolean

Whether a third party reviewed the application; null when unspecified.

string

Whether the application provides a statement or a summary. null when the source gives no value.

curl -X POST https://win.oneshotagent.com/v1/tools/lookup/product-device-clearances \
  -H "Content-Type: application/json" \
  -H "payment-signature: <base64 x402 payment>" \
  -d '{
    "applicant": "Apple Inc",
    "limit": 2
  }'

const response = await fetch("https://win.oneshotagent.com/v1/tools/lookup/product-device-clearances", {
  method: "POST",
  headers: {
    "Content-Type": "application/json",
    "payment-signature": paymentProof,
  },
  body: JSON.stringify({
    "applicant": "Apple Inc",
    "limit": 2
  }),
});

const result = await agent.tool('lookup/product-device-clearances', {
  applicant: 'Apple Inc',
  limit: 2
});
console.log(result.data.result);
console.log(result.data.evidence);

{
  "success": true,
  "data": {
    "request_id": "uuid",
    "receipt_id": "rcpt_...",
    "status": "completed",
    "tool": "product_device_clearances",
    "result": {
      "total": 12,
      "clearances": [
        {
          "k_number": "K253582",
          "device_name": "Medical Imaging Calibration Feature (MICF)",
          "applicant": "Apple, Inc.",
          "city": "Cupertino",
          "state": "CA",
          "country_code": "US",
          "product_code": "SHN",
          "device_class": "1",
          "regulation_number": "892.1940",
          "medical_specialty": "Radiology",
          "decision": "Substantially Equivalent",
          "decision_code": "SESE",
          "decision_date": "2026-04-01",
          "received_date": "2025-11-17",
          "clearance_type": "Traditional",
          "third_party_review": false,
          "summary_type": "Summary"
        },
        {
          "k_number": "K250507",
          "device_name": "Hypertension Notification Feature (HTNF)",
          "applicant": "Apple, Inc.",
          "city": null,
          "state": null,
          "country_code": null,
          "product_code": "SFR",
          "device_class": "2",
          "regulation_number": "870.2380",
          "medical_specialty": "Cardiovascular",
          "decision": "Substantially Equivalent",
          "decision_code": "SESE",
          "decision_date": "2025-09-11",
          "received_date": "2025-02-21",
          "clearance_type": "Traditional",
          "third_party_review": null,
          "summary_type": null
        }
      ]
    },
    "evidence": {
      "source": "US Food and Drug Administration",
      "source_kind": "public",
      "retrieved_at": "2026-10-15T12:00:00.000Z",
      "calls": [
        {
          "retrieved_at": "2026-10-15T12:00:00.000Z"
        }
      ],
      "as_of": "2026-10-05"
    }
  }
}

See Pricing for this tool’s price. A wallet (x402) call receives it in the 402 quote before anything is charged; a call paid from prepaid credits is charged when the API accepts the request and answers 200.

Notes

Results return inline. The finished job stays available at /v1/requests/{request_id}

Overview

Compute

Data

Monitoring

Research & Enrich

Messaging

Web & Browser

Build

Commerce

Account & billing

Other

Device Clearances

Authentication

Request Body

Response (200 OK)

Result

Notes

​Authentication

​Request Body

​Response (200 OK)

​Result

​Notes

Authentication

Request Body

Response (200 OK)

Result

Notes