FDA 510(k) Medical Device Clearance Lookup

x402

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.

Price / call$0.005

Seller volume →—

Success—

StatusUnknown

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.

Example use cases

Verify competitor device clearance status

“Look up the 10 most recent FDA 510(k) clearances granted to Abbott Laboratories for their cardiac devices — I want to see what they've gotten cleared recently.”

Retrieve clearance by K number

“Can you pull up the FDA 510(k) clearance record for K253582? I need the decision and device details.”

Research cleared devices by product code

“Find me the latest 15 FDA 510(k) clearances under product code FPA so I can see what similar devices have been approved.”

Technical details

Endpoint

POSThttps://win.oneshotagent.com/v1/tools/lookup/product-device-clearances?utm_source=zero.xyz

When to prefer

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.

Side effects

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

Input

Schema · Request body

Field	Type	Description
limit	integer	The most clearance records to return. From 1 to 25. Defaults to `10`.
k_number	string	The clearance number, for example K253582
applicant	string	The company that applied, matched as words. 2 to 100 characters.
device_name	string	The device name, matched as words. 2 to 100 characters.
product_code	string	The FDA product code

Output

Schema · Response

{
  "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
      }
    ]
  }
}

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