# FDA Medical Device Classification Lookup

> FDA Medical Device Classification Lookup is a paid API for AI agents from 2s.io, paid per call via x402, $0.0018/call, status unknown (last checked 2026-09-14).

Looks up FDA medical device classifications by device name or product code, returning regulatory class, submission type, specialty, and safety flags.

## Facts

- Endpoint: GET https://2s.io/api/medical/device-classification
- Price: $0.0018/call
- Payment: x402
- Status: unknown
- Last checked: 2026-09-14
- Activations on Zero: 0
- Tags: x402
- Canonical page: https://www.zero.xyz/c/fda-medical-device-classification-lookup-39b596ca
- Structured record (JSON): https://api.zero.xyz/v1/capabilities/cap_fjIl0etMPRgfXl_SB25Jt

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-medical-device-classification-lookup-39b596ca
```

Example prompt: Look up the FDA classification for 'catheter' — I need the device class, submission type, medical specialty, and whether it's a life-sustaining or implantable device. Return up to 5 results.

## When to prefer this

Use this endpoint when you need authoritative FDA regulatory classification data for a medical device — specifically the device class, submission pathway, review panel, or safety flags (implant, life-sustaining). Prefer this over general web search when you need structured, machine-readable regulatory ground-truth for compliance, due diligence, or medical device research tasks.

## Known failure modes

- No results returned if device name or product code doesn't match any FDA record
- Invalid product code format may return empty results
- Limit parameter out of range (1-50) causes validation error
- Ambiguous partial device name may return unrelated device types
- OpenFDA upstream outage may cause 502/503 errors

## How this service works

FDA medical device classification — the regulatory class and controls for a device type. Search by device name or FDA product code and get back the device class (I/II/III, mapping to regulatory risk and controls), CFR regulation number, medical specialty/review panel, the official definition, and flags for life-sustaining/supporting, implant, GMP-exempt, and third-party-review eligibility. Free, public-domain US government data. The authoritative answer to "what FDA class is this device and what regulation governs it" — for regulatory and medical-device diligence; point-in-time public records, not regulatory advice.

## Output

Returns an array of FDA device classification records, each including device name, class (I/II/III), 3-letter product code, review panel, submission type, medical specialty, CFR regulation number, and boolean flags for implant status, life-sustain/support, GMP exemption, and third-party review eligibility. Also includes total count of matching records and the data source (OpenFDA).

## 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",
    "queryParams"
   ],
   "properties": {
    "type": {
     "const": "http"
    },
    "method": {
     "const": "GET"
    },
    "queryParams": {
     "properties": {
      "limit": {
       "type": "integer",
       "default": 10,
       "maximum": 50,
       "minimum": 1
      },
      "device": {
       "type": "string",
       "description": "Device name (partial)."
      },
      "productCode": {
       "type": "string",
       "description": "FDA product code (3-letter)."
      }
     }
    }
   }
  }
 }
}
```

## More

- Live health (JSON, refreshed every minute): https://www.zero.xyz/c/fda-medical-device-classification-lookup-39b596ca/health.json
- [Zero catalog index](https://www.zero.xyz/llms.txt)
- [Other services from 2s.io](https://www.zero.xyz/host/2s.io/llms.txt)