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Initial card for device-classifications
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metadata
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.

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

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.}
}

Related


Maintained by AI Analytics. Data is CC0; please cite the upstream agency.