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# Class 2 for Isocapnic Ventilation Devices
- URL: https://www.fdaweb.com/class-2-for-isocapnic-ventilation-devices/
- Published: 2021-12-01T12:00:00.000Z
- Updated: 2026-09-14T17:24:12.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5150674

*Federal Register* notice: FDA is classifying isocapnic ventilation devices into Class 2 (special controls), following a de novo classification request from Thornhill Research for its ClearMate device. The agency has identified it as a prescription device used to administer a blend of carbon dioxide and oxygen gases to a patient to induce hyperventilation. This device may be labeled for use with breathing circuits made of reservoir bags, oxygen cannulas, masks, valves, resuscitation bags, and/or tubing. To view the notice, click [here](https://public-inspection.federalregister.gov/2021-26201.pdf?ref=fdaweb.com).