# 2s FDA Medical Device 510(k) Clearance Lookup

> 2s FDA Medical Device 510(k) Clearance Lookup is a paid API for AI agents from 2s.io, paid per call via x402, $0.0018/call, status unknown (last checked 2026-09-14).

Searches FDA 510(k) clearance records by device name, applicant/manufacturer, or product code, returning official clearance details including K-number, decision date, and advisory committee.

## Facts

- Endpoint: GET https://2s.io/api/medical/device-510k
- Price: $0.0018/call
- Payment: x402
- Status: unknown
- Last checked: 2026-09-14
- Activations on Zero: 0
- Tags: x402
- Canonical page: https://www.zero.xyz/c/2s-fda-medical-device-510-k-clearance-lookup-a92ae07b
- Structured record (JSON): https://api.zero.xyz/v1/capabilities/cap_PTXb6SbZSHS-nrCkfIUu3

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 2s-fda-medical-device-510-k-clearance-lookup-a92ae07b
```

Example prompt: Can you search the FDA 510(k) clearance database for pacemaker devices made by Medtronic and show me up to 10 results, including their K-numbers and decision dates?

## When to prefer this

Use this endpoint when you need authoritative FDA 510(k) clearance data, including K-numbers, decision dates, and clearance type classifications. Prefer this over general web searches when you need structured, machine-readable regulatory records for medical devices. Ideal for compliance research, due diligence, competitive intelligence on medical device manufacturers, or verifying whether a specific device has received FDA clearance.

## Known failure modes

- No matching records found for the given query parameters — returns empty clearances array with totalCount 0
- Invalid product code format (not 3-letter) may return empty results or error
- Limit parameter out of range (must be 1–50) returns validation error
- Partial device name too vague may return unrelated results
- OpenFDA upstream outage may cause failed or delayed responses

## How this service works

FDA 510(k) premarket clearances — the record of medical devices cleared for US marketing by demonstrating substantial equivalence to a predicate device. Search by device name, applicant (manufacturer), or FDA product code, and get back each clearance with its K-number, device name, applicant, decision date and decision description, clearance type (traditional/special/abbreviated), product code, advisory committee, and date received — newest decision first. Free, public-domain US government data. Authoritative regulatory-status data for medical-device diligence; point-in-time public records, not regulatory advice.

## Output

Returns a list of FDA 510(k) clearance records matching the query, each with K-number, applicant/manufacturer name, device name, FDA product code, date received, decision date, clearance type (e.g. Traditional), advisory committee (e.g. Cardiovascular), decision description (e.g. Substantially Equivalent), and state/country. Also includes total count of matching records and the data source attribution.

## Request schema (JSON Schema)

```json
{
 "type": "object",
 "$schema": "https://json-schema.org/draft/2020-12/schema",
 "required": [
  "input"
 ],
 "properties": {
  "input": {
   "type": "object",
   "required": [
    "type",
    "method",
    "queryParams"
   ],
   "properties": {
    "type": {
     "const": "http"
    },
    "method": {
     "const": "GET"
    },
    "queryParams": {
     "properties": {
      "limit": {
       "type": "integer",
       "default": 10,
       "maximum": 50,
       "minimum": 1
      },
      "device": {
       "type": "string",
       "description": "Device name (partial)."
      },
      "applicant": {
       "type": "string",
       "description": "Applicant / manufacturer name."
      },
      "productCode": {
       "type": "string",
       "description": "FDA product code (3-letter, e.g. DXY)."
      }
     }
    }
   }
  }
 }
}
```

## More

- Live health (JSON, refreshed every minute): https://www.zero.xyz/c/2s-fda-medical-device-510-k-clearance-lookup-a92ae07b/health.json
- [Zero catalog index](https://www.zero.xyz/llms.txt)
- [Other services from 2s.io](https://www.zero.xyz/host/2s.io/llms.txt)