21 C.F.R. § 868.5450
Respiratory gas humidifier.
Cite as 21 C.F.R. § 868.5450 (2026)
(a) Identification. A respiratory gas humidifier is a device that is intended to add moisture to, and sometimes to warm, the breathing gases for administration to a patient. Cascade, gas, heated, and prefilled humidifiers are included in this generic type of device. (b) Classification. Class II (performance standards).