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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
# 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 / 17 USC 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
@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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Maintained by AI Analytics. Data is CC0; please cite the upstream agency.
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