# K964653: Oasis Humidifier

- Pathway: 510(k) (Traditional)
- Applicant: Respironics, Inc.
- Decided: Feb 14, 1997 after 86 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
Longest line of descent: 1 generation back to K945782 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K945782: Humidifier, Respironics, Inc. (1996) Summary page 1.

## Indications for use
The Oasis Humidifier is an accessory for Respironics CPAP and BiPAP systems to provide moisture to the patient circuit. The Oasis is the only humidifier with the acoustical design that enables effective operation of Respironics’ Auto-CPAP mode. As such, it is the only humidifier that can be used with Respironics’ Auto-CPAP products (i.e., Virtuoso Smart CPAP System (K953930) and Quartet Clinical System (K963761, currently under review)). The Oasis can also be used with standard CPAP devices from other manufacturers which have maximum operating pressures of 20 cm HpO, and do not have bi-level or automatic pressure titration capabilities. Performance of non-Respironics CPAP systems with the Oasis humidifier should be verified before use.

Source page: https://510kreport.com/device/K964653
Methodology: https://510kreport.com/methodology