# openFDA Device 510(k) Clearances Search

> openFDA Device 510(k) Clearances Search is a paid API for AI agents from proxy.suverse.io, paid per call via x402, $0.004/call, status unknown (last checked 2026-09-16).

Queries the FDA's Device 510(k) Clearances public dataset by search expression and returns matching structured records for medical device regulatory research.

## Facts

- Endpoint: POST https://proxy.suverse.io/v1/data/suverse-openfda-device-510k
- Price: $0.004/call
- Payment: x402
- Status: unknown
- Last checked: 2026-09-16
- Activations on Zero: 0
- Tags: x402
- Canonical page: https://www.zero.xyz/c/openfda-device-510-k-clearances-search-f56e600c
- Structured record (JSON): https://api.zero.xyz/v1/capabilities/cap_x3I5QKeAmexNwXU0NFiYB

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 openfda-device-510-k-clearances-search-f56e600c -d '<json body>'
```

Example prompt: Search the FDA 510(k) clearance database for all cleared devices with 'glucose monitor' in the device name and tell me what companies received clearances in the last few years.

## When to prefer this

Choose this endpoint when you need structured, machine-readable access to FDA 510(k) medical device clearance records without managing an FDA API key. It is ideal for pharma researchers, regulatory analysts, AI agents in device safety workflows, or competitive intelligence tasks that require querying the public openFDA device dataset programmatically at low cost per call.

## Known failure modes

- Invalid or unsyntactically incorrect search expression returns an error or empty results
- No matching records found for the given query returns an empty result set
- OpenFDA upstream API unavailability may cause timeout or 5xx error
- Overly broad search expressions may hit result limits and return truncated datasets
- Malformed POST body or missing required fields returns a 400-level error

## How this service works

Query the openFDA Device 510(k) Clearances dataset by search expression, no key, US FDA public data. Returns matching records with structured fields. For AI agents in pharma, device, and safety research.

## Output

Returns an array of structured 510(k) clearance records from the FDA openFDA dataset, each containing fields such as the device name, applicant name, K-number (clearance number), decision date, product code, device class, submission type, and regulatory decision outcome.

## 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",
    "bodyType",
    "body"
   ],
   "properties": {
    "body": {
     "properties": {}
    },
    "type": {
     "type": "string",
     "const": "http"
    },
    "method": {
     "enum": [
      "POST",
      "PUT",
      "PATCH"
     ],
     "type": "string"
    },
    "bodyType": {
     "enum": [
      "json",
      "form-data",
      "text"
     ],
     "type": "string"
    }
   },
   "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/openfda-device-510-k-clearances-search-f56e600c/health.json
- [Zero catalog index](https://www.zero.xyz/llms.txt)
- [Other services from proxy.suverse.io](https://www.zero.xyz/host/proxy.suverse.io/llms.txt)