---
license: cc0-1.0
task_categories:
  - text-classification
  - tabular-classification
  - tabular-regression
language:
  - en
tags:
  - federal
  - government
  - regulatory
  - united-states
  - public-data
  - cc0
  - us-food-and-drug-administration
  - fda-device-classification
  - product-code
  - class-i
pretty_name: "FDA Medical Device Classifications"
size_categories:
  - unknown
homepage: https://api.ai-analytics.org/datasets/device-classifications
---

# FDA Medical Device Classifications (7,058 product codes — the device taxonomy)

Every FDA-classified medical device type. The foundational regulatory taxonomy of the entire US medical device industry — every device sold in the US falls under one of 7,058 product codes. Each entry has the 3-letter product code (OWW for surgical drills, DXP for X-ray systems, KNT for orthopedic implants), device name, regulatory definition, device class (Class I low-risk / Class II 510(k) / Class III PMA high-risk), 21 CFR regulation number, review panel, medical specialty, submission type, and counts of cleared 510(k) submissions + registered establishments. schema.org/MedicalDevice JSON-LD with FDA Product Code identifier, 21 CFR reference, and clearance route. Source: api.fda.gov/device/classification.json (openFDA).

## Live API

This dataset is served via a **live REST API** at `api.ai-analytics.org`. The card you're reading exists so HuggingFace's index can route AI agents + researchers to the canonical source.

- **API endpoint**: `https://api.ai-analytics.org/api/v1/devices/classifications/recent`
- **Dataset landing page**: <https://api.ai-analytics.org/datasets/device-classifications>
- **DataCatalog (JSON-LD)**: <https://api.ai-analytics.org/.well-known/dataset.json>
- **DCAT-US (data.gov-compatible)**: <https://api.ai-analytics.org/data.json>

### Quick start

```bash
# Recent records (JSON)
curl 'https://api.ai-analytics.org/api/v1/devices/classifications/recent?limit=10'

# Browse on the web
open 'https://api.ai-analytics.org/datasets/device-classifications'
```

### MCP (Model Context Protocol)

This dataset is also accessible via MCP at `https://api.ai-analytics.org/mcp` — Claude, ChatGPT, and other MCP-compatible agents can call it directly.

## Source

- **Agency**: US Food and Drug Administration
- **Primary source**: <https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm>
- **License**: CC0 1.0 Universal (derived data). Underlying federal works are US public domain under [5 USC 105](https://www.law.cornell.edu/uscode/text/5/105) / [17 USC 105](https://www.law.cornell.edu/uscode/text/17/105).
- **Update cadence**: Per agency (most refresh daily via Cloudflare Cron Trigger)

## Keywords

FDA device classification, product code, Class I, Class II, Class III, 510(k), PMA, medical device, device taxonomy, 21 CFR

## Citation

```bibtex
@misc{ai_analytics_device_classifications_2026,
  title  = {{name}},
  author = {AI Analytics},
  year   = {2026},
  url    = {https://api.ai-analytics.org/datasets/device-classifications},
  note   = {Derived from US Food and Drug Administration. License: CC0 1.0.}
}
```

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- [OpenAPI 3.1 spec](https://api.ai-analytics.org/openapi.json)
- [llms.txt for AI agents](https://api.ai-analytics.org/llms.txt)

---
*Maintained by [AI Analytics](https://ai-analytics.org). Data is CC0; please cite the upstream agency.*