# FDA 510(k) Device Clearances Search

> FDA 510(k) Device Clearances Search is a paid API for AI agents from agent402.tools, paid per call via x402, $0.004/call, status unknown (last checked 2026-10-17).

Search FDA 510(k) premarket clearance records by applicant, product code, K number, or device name, returning decision details, clearance type, device class, and regulation info.

## Facts

- Endpoint: GET https://agent402.tools/api/device-510k?utm_source=zero.xyz
- Price: $0.004/call
- Payment: x402
- Status: unknown
- Last checked: 2026-10-17
- Activations on Zero: 0
- Tags: x402
- Canonical page: https://www.zero.xyz/c/fda-510-k-device-clearances-search-a405ff11
- Structured record (JSON): https://api.zero.xyz/v1/capabilities/cap_EjQrtD1xMngJIkf4L_IrM

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-device-clearances-search-a405ff11
```

Example prompt: Can you look up the most recent FDA 510(k) clearances for Medtronic — show me up to 10 results with their decision dates, device classes, and links to the FDA records?

## When to prefer this

Use this endpoint when you need to look up FDA 510(k) premarket clearance records directly from live FDA data without requiring an API key. It is ideal for regulatory research, competitive intelligence on medical device companies, verifying specific clearances by K number, or exploring which devices have been cleared under a particular product code or FDA classification. Prefer this over manual FDA website searches when you need structured, machine-readable results.

## Known failure modes

- No matches found if the K number, product code, or applicant name is misspelled or doesn't exist in FDA data
- Partial results if more clearances exist than the requested limit (truncated flag set to true)
- API timeout or unavailability if the upstream openFDA service is down
- Invalid query parameter types (e.g. non-numeric limit) may cause request failure
- Product codes that don't correspond to any 510(k) records return zero results

## How this service works

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

## Output

Returns a structured response with the total number of matched clearances, and for each clearance: the K number, applicant name, device name, decision date, clearance type, device class, FDA regulation number, FDA classification name, medical specialty, and a link to the official FDA record. Results are sorted newest decision first. Includes flags for whether results are truncated and a data disclaimer.

## 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"
   ],
   "properties": {
    "type": {
     "type": "string",
     "const": "http"
    },
    "method": {
     "enum": [
      "GET"
     ],
     "type": "string"
    },
    "queryParams": {
     "type": "object",
     "required": [],
     "properties": {
      "limit": {
       "type": "number",
       "description": "Clearances to return, 1-20 (default 5)"
      },
      "kNumber": {
       "type": "string",
       "description": "510(k) number, e.g. K233210"
      },
      "applicant": {
       "type": "string",
       "description": "Applicant (company) name, e.g. medtronic"
      },
      "deviceName": {
       "type": "string",
       "description": "Device name as submitted, e.g. insulin pump"
      },
      "productCode": {
       "type": "string",
       "description": "Three-letter FDA product code, e.g. LZG"
      }
     }
    }
   },
   "additionalProperties": false
  },
  "output": {
   "type": "object",
   "required": [
    "type"
   ],
   "properties": {
    "type": {
     "type": "string"
    },
    "example": {
     "type": "object",
     "required": [
      "query",
      "count",
      "clearances",
      "returned",
      "matched",
      "complete",
      "truncated",
      "disclaimer",
      "source"
     ],
     "properties": {
      "count": {
       "type": "integer"
      },
      "query": {
       "type": "object"
      },
      "source": {
       "type": "string"
      },
      "matched": {
       "type": "integer"
      },
      "complete": {
       "type": "boolean"
      },
      "returned": {
       "type": "integer"
      },
      "truncated": {
       "type": "boolean"
      },
      "clearances": {
       "type": "array"
      },
      "disclaimer": {
       "type": "string"
      }
     }
    }
   }
  }
 }
}
```

## More

- Live health (JSON, refreshed every minute): https://www.zero.xyz/c/fda-510-k-device-clearances-search-a405ff11/health.json
- [Zero catalog index](https://www.zero.xyz/llms.txt)
- [Other services from agent402.tools](https://www.zero.xyz/host/agent402.tools/llms.txt)