# FDA 510(k) Device Clearances

> FDA 510(k) Device Clearances is a paid API for AI agents from x402-filings.datalayer.workers.dev, paid per call via x402, $0.02/call, status unknown (last checked 2026-10-13).

Retrieves FDA 510(k) medical device clearance records including device name, applicant, decision date, product code, device class, regulation number, and advisory committee, with clearances-per-year breakdown.

## Facts

- Endpoint: GET https://x402-filings.datalayer.workers.dev/v1/fda/device-clearances?utm_source=zero.xyz
- Price: $0.02/call
- Payment: x402
- Status: unknown
- Last checked: 2026-10-13
- Activations on Zero: 0
- Tags: x402
- Canonical page: https://www.zero.xyz/c/fda-510-k-device-clearances-4cd6c8da
- Structured record (JSON): https://api.zero.xyz/v1/capabilities/cap_yXVaF6-PxQUFIAle0KlK7

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-4cd6c8da
```

Example prompt: Can you look up FDA 510(k) clearances for catheter devices from Medtronic, show me up to 50 results, and include decisions made between 2020-01-01 and 2024-12-31?

## When to prefer this

Use this endpoint when you need structured, searchable FDA 510(k) clearance data for medical devices — especially for medtech due diligence, regulatory verification, or competitive research. Pairs with the FDA adverse-events and enforcement endpoints on the same provider for comprehensive regulatory picture. Prefer over manual FDA database searches when programmatic, filterable access by device name, company, K-number, or date range is needed.

## Known failure modes

- No records found for an obscure or misspelled device name — returns empty result set
- K-number format mismatch (e.g. missing leading K) returns no results
- Date range too narrow returns empty list
- limit parameter out of range (not 1-100) may return validation error
- Applicant name variation (abbreviation vs full legal name) may miss records

## How this service works

FDA 510(k) clearances for medical devices: which devices were cleared to market, the applicant, the decision date, product code, device class, regulation number and advisory committee, plus a clearance-per-year breakdown. Search by device name, applicant company or K-number. Pairs with the adverse-events and enforcement endpoints for full medtech diligence.

## Output

Returns a list of FDA 510(k) clearance records, each containing the device name, applicant company, decision date, K-number, product code, device class, regulation number, and advisory committee. Also includes a clearances-per-year breakdown for trend analysis. Results are filterable by device name keyword, applicant, K-number, and date range.

## 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",
     "properties": {
      "to": {
       "type": "string",
       "examples": [
        "2026-08-24"
       ],
       "description": "Decision on or before, ISO date."
      },
      "from": {
       "type": "string",
       "examples": [
        "2024-01-01"
       ],
       "description": "Decision on or after, ISO date."
      },
      "limit": {
       "type": "integer",
       "examples": [
        25
       ],
       "description": "Max clearances, 1-100. Default 25."
      },
      "device": {
       "type": "string",
       "examples": [
        "catheter"
       ],
       "description": "Device name to search."
      },
      "kNumber": {
       "type": "string",
       "examples": [
        "K123456"
       ],
       "description": "Exact 510(k) number, e.g. K123456."
      },
      "applicant": {
       "type": "string",
       "examples": [
        "Medtronic"
       ],
       "description": "Applicant company name."
      }
     }
    }
   },
   "additionalProperties": false
  },
  "output": {
   "type": "object",
   "required": [
    "type"
   ],
   "properties": {
    "type": {
     "type": "string"
    },
    "example": {
     "type": "object"
    }
   }
  }
 }
}
```

## More

- Live health (JSON, refreshed every minute): https://www.zero.xyz/c/fda-510-k-device-clearances-4cd6c8da/health.json
- [Zero catalog index](https://www.zero.xyz/llms.txt)
- [Other services from x402-filings.datalayer.workers.dev](https://www.zero.xyz/host/x402-filings.datalayer.workers.dev/llms.txt)