# K945782: Humidifier

- Pathway: 510(k) (Traditional)
- Applicant: Respironics, Inc.
- Decided: Mar 1, 1996 after 462 days
- Product code: BTT (Humidifier, Respiratory Gas, (Direct Patient Interface))
- Device class: 2
- Regulation: 21 CFR 868.5450
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K964653: Oasis Humidifier (1997), 0 descendants of its own

## Indications for use
The Respironics Humidifier is intended to add vapor phase moisture to the airstream provided to the patient by the Respironics BiPAP or CPAP systems. The Humidifier is a “passover” style which increases moisture content of the airstream by allowing the airstream to pass over a tray of water and absorb water by evaporation into the airstream.

Source page: https://510kreport.com/device/K945782
Methodology: https://510kreport.com/methodology