# SiteCheck Health & Travel – FDA 510(k) Premarket Notifications

> SiteCheck Health & Travel – FDA 510(k) Premarket Notifications is a paid API for AI agents from api.healthtravel-api.workers.dev, paid per call via x402, $0.002/call, status unknown (last checked 2026-10-29).

Searches FDA 510(k) premarket notification clearance records by device name, returning K-number, applicant, decision, dates, and product code for up to 10 results.

## Facts

- Endpoint: GET https://api.healthtravel-api.workers.dev/api/health/fda-medical-device-510k?utm_source=zero.xyz
- Price: $0.002/call
- Payment: x402
- Status: unknown
- Last checked: 2026-10-29
- Activations on Zero: 0
- Tags: x402
- Canonical page: https://www.zero.xyz/c/sitecheck-health-travel-fda-510-k-premarket-notifications-168b3425
- Structured record (JSON): https://api.zero.xyz/v1/capabilities/cap_FN8dsbm2vekQItJW0ffl3

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 sitecheck-health-travel-fda-510-k-premarket-notifications-168b3425
```

Example prompt: Can you look up the FDA 510(k) clearance records for 'glucose monitor' and show me up to 8 results — I need the K-number, applicant, and decision for each?

## When to prefer this

Use this endpoint when you need to search FDA 510(k) premarket notification clearance records by device name. It is ideal for regulatory research, compliance verification, due diligence, and competitive intelligence on cleared medical devices. Prefer this over FDA Purple Book (which covers biologics) or AccessGUDID (which looks up by Device Identifier barcode number) when you have a device name and need clearance history and K-numbers.

## Known failure modes

- Query string too short (under 2 chars) or too long (over 60 chars) returns validation error
- No matching 510(k) records found for the search term returns empty result set
- openFDA upstream service unavailable causes timeout or 5xx error
- Invalid 'max' value outside 1–10 range may be rejected or defaulted
- Rate limiting or payment failure due to x402 protocol issues

## How this service works

FDA 510(k) premarket notifications (openFDA): K-number, device name, applicant, decision (e.g. Substantially Equivalent), decision and received dates, product code and advisory committee. Up to 10 per call.

## Output

Returns up to 10 FDA 510(k) premarket notification records from openFDA, each containing: K-number, device name, applicant name, decision (e.g. Substantially Equivalent), decision date, received date, product code, and advisory committee classification.

## 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": [
      "q"
     ],
     "properties": {
      "q": {
       "type": "string",
       "description": "Device name words, letters, digits and spaces, 2 to 60 characters"
      },
      "max": {
       "type": "string",
       "description": "How many clearances, 1 to 10 (default 5)"
      }
     }
    }
   },
   "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/sitecheck-health-travel-fda-510-k-premarket-notifications-168b3425/health.json
- [Zero catalog index](https://www.zero.xyz/llms.txt)
- [Other services from api.healthtravel-api.workers.dev](https://www.zero.xyz/host/api.healthtravel-api.workers.dev/llms.txt)