# FDA 510(k) Medical Device Clearance Lookup

> FDA 510(k) Medical Device Clearance Lookup is a paid API for AI agents from win.oneshotagent.com, paid per call via x402, $0.005/call, status unknown (last checked 2026-10-29).

Look up US FDA 510(k) medical device clearances and their decisions, sorted newest first.

## Facts

- Endpoint: POST https://win.oneshotagent.com/v1/tools/lookup/product-device-clearances?utm_source=zero.xyz
- Price: $0.005/call
- Payment: x402
- Status: unknown
- Last checked: 2026-10-29
- Activations on Zero: 0
- Tags: x402
- Canonical page: https://www.zero.xyz/c/fda-510-k-medical-device-clearance-lookup-cd5aebcf
- Structured record (JSON): https://api.zero.xyz/v1/capabilities/cap_cDiltXhQ7HaN63Li_aHiI

Status and success rate cover calls made through Zero and Zero's own probes. Third-party monitors may report differently.

## How to call it through Zero

Zero handles the 402 payment challenge and records the run. With the Zero CLI installed (`npm i -g @zeroxyz/cli`):

```sh
zero fetch --capability fda-510-k-medical-device-clearance-lookup-cd5aebcf -d '<json body>'
```

Example prompt: Can you look up the FDA 510(k) clearance records for Medtronic's glucose monitoring devices — show me the 5 most recent clearances?

## When to prefer this

Use this endpoint when you need to look up official US FDA 510(k) clearance records for medical devices, whether searching by K number, company name, device name, or FDA product code. Prefer this over general web search when you need structured, authoritative clearance data directly from the FDA database. Best suited for regulatory research, competitive intelligence on cleared devices, and compliance verification workflows.

## Known failure modes

- No records found for the given search criteria — returns empty result set
- Invalid K number format — the k_number field must match the standard format (e.g. K253582)
- applicant or device_name string too short (under 2 characters) or too long (over 100 characters) — validation error
- limit out of range — must be between 1 and 25
- Payment failure — x402 payment of $0.005 USDC not fulfilled

## How this service works

Look up US medical device 510(k) clearances and their decisions, newest decision first.

## Output

Returns a list of 510(k) clearance records sorted newest-first, each containing the K number, applicant name, device name, FDA product code, decision, and decision date — up to 25 records per call.

## Request schema (JSON Schema)

```json
{
 "type": "object",
 "properties": {
  "limit": {
   "type": "integer",
   "description": "The most clearance records to return. From 1 to 25. Defaults to `10`."
  },
  "k_number": {
   "type": "string",
   "description": "The clearance number, for example K253582"
  },
  "applicant": {
   "type": "string",
   "description": "The company that applied, matched as words. 2 to 100 characters."
  },
  "device_name": {
   "type": "string",
   "description": "The device name, matched as words. 2 to 100 characters."
  },
  "product_code": {
   "type": "string",
   "description": "The FDA product code"
  }
 }
}
```

## Response schema (JSON Schema)

```json
{
 "type": "json",
 "example": {
  "total": 12,
  "clearances": [
   {
    "city": "Cupertino",
    "state": "CA",
    "decision": "Substantially Equivalent",
    "k_number": "K253582",
    "applicant": "Apple, Inc.",
    "device_name": "Medical Imaging Calibration Feature (MICF)",
    "country_code": "US",
    "device_class": "1",
    "product_code": "SHN",
    "summary_type": "Summary",
    "decision_code": "SESE",
    "decision_date": "2026-04-01",
    "received_date": "2025-11-17",
    "clearance_type": "Traditional",
    "medical_specialty": "Radiology",
    "regulation_number": "892.1940",
    "third_party_review": false
   },
   {
    "city": null,
    "state": null,
    "decision": "Substantially Equivalent",
    "k_number": "K250507",
    "applicant": "Apple, Inc.",
    "device_name": "Hypertension Notification Feature (HTNF)",
    "country_code": null,
    "device_class": "2",
    "product_code": "SFR",
    "summary_type": null,
    "decision_code": "SESE",
    "decision_date": "2025-09-11",
    "received_date": "2025-02-21",
    "clearance_type": "Traditional",
    "medical_specialty": "Cardiovascular",
    "regulation_number": "870.2380",
    "third_party_review": null
   }
  ]
 }
}
```

## More

- Live health (JSON, refreshed every minute): https://www.zero.xyz/c/fda-510-k-medical-device-clearance-lookup-cd5aebcf/health.json
- [Zero catalog index](https://www.zero.xyz/llms.txt)
- [Other services from win.oneshotagent.com](https://www.zero.xyz/host/win.oneshotagent.com/llms.txt)