# Stratalize FDA 510(k) Device Clearance History

> Stratalize FDA 510(k) Device Clearance History is a paid API for AI agents from www.stratalize.com, paid per call via x402, $0.1/call, status unknown (last checked 2026-09-14).

Returns FDA 510(k) clearance history for a medical device by name, including K numbers, applicants, decisions, and receipt dates from the OpenFDA database.

## Facts

- Endpoint: GET https://www.stratalize.com/api/x402/device-clearances
- Price: $0.1/call
- Payment: x402
- Status: unknown
- Last checked: 2026-09-14
- Activations on Zero: 0
- Tags: x402
- Canonical page: https://www.zero.xyz/c/stratalize-fda-510-k-device-clearance-history-e6b36f49
- Structured record (JSON): https://api.zero.xyz/v1/capabilities/cap_iaUoDmthDTbF3M0YGBiSL

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 stratalize-fda-510-k-device-clearance-history-e6b36f49
```

Example prompt: Can you pull the FDA 510(k) clearance history for pulse oximeters — I need the K numbers, applicant names, and decision dates for competitive intelligence on who's cleared in that space?

## When to prefer this

Use this endpoint when you need structured FDA 510(k) clearance history by device name for medtech competitive intelligence, regulatory pathway research, or supplier qualification. Prefer this over manual FDA database searches when you need machine-readable results with cryptographic provenance verification.

## Known failure modes

- Device name not found in FDA 510(k) database — returns empty result set
- Overly generic device name returns too many records or is ambiguous
- OpenFDA source data lag may mean very recent clearances are not yet reflected
- Payment failure results in HTTP 402 before data is returned
- Malformed device_name parameter returns error

## How this service works

Stratalize — attested finance, legal, healthcare, and compliance intelligence. Signed, independently verifiable receipt on every call (trust.stratalize.com/verify). FDA 510(k) device clearance history from OpenFDA by device name. Returns K numbers, applicants, decisions, and receipt dates. Use for medtech competitive intelligence, regulatory pathway research, and supplier qualification. Source: FDA 510(k) database. $0.10 standard

## Output

A list of FDA 510(k) clearance records for the queried device name, including K numbers, applicant/company names, regulatory decisions (e.g. cleared/not cleared), and receipt dates. Each response is ML-DSA-65 cryptographically signed with a verifiable receipt at trust.stratalize.com/verify.

## Request schema (JSON Schema)

```json
{
 "type": "object",
 "properties": {
  "device_name": {
   "type": "string",
   "description": "Request parameter: device name"
  }
 }
}
```

## More

- Live health (JSON, refreshed every minute): https://www.zero.xyz/c/stratalize-fda-510-k-device-clearance-history-e6b36f49/health.json
- [Zero catalog index](https://www.zero.xyz/llms.txt)
- [Other services from www.stratalize.com](https://www.zero.xyz/host/www.stratalize.com/llms.txt)