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# Class 2 for Humidified Oxygen Delivery Devices
- URL: https://www.fdaweb.com/class-2-for-humidified-oxygen-delivery-devices/
- Published: 2018-10-29T12:00:00.000Z
- Updated: 2026-09-15T00:41:06.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5142688

*Federal Register* notice: FDA has classified high-flow humidified oxygen delivery devices into Class 2 (special controls). FDA’s action is based on a 1/2017 Vapotherm *de novo* classification request for its Precision Flow HVNI, which is identified as a prescription device that delivers high flow oxygen with humidification for patients who are suffering from respiratory distress or hypoxemia. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2018-10-26/pdf/2018-23409.pdf?ref=fdaweb.com).