| --- |
| 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.} |
| } |
| ``` |
|
|
| ## Related |
|
|
| - [Full data catalog (100 datasets)](https://api.ai-analytics.org/datasets/) |
| - [Unified compliance screening (30+ enforcement lists)](https://api.ai-analytics.org/api/v1/screening/all) |
| - [Cross-vertical entity timeline](https://api.ai-analytics.org/api/v1/entity/AAPL/timeline) |
| - [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.* |
|
|
