# K253044: RXiBreeze PAP System (RXiBreeze 20C)

- Pathway: 510(k) (Traditional)
- Applicant: Resvent Medical Technology Co., Ltd.
- Decided: Jul 23, 2026 after 304 days
- Product code: BZD (Ventilator, Non-Continuous (Respirator))
- Device class: 2
- Regulation: 21 CFR 868.5905
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K953930 (1996). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153387: Luna CPAP and Auto CPAP System, 3B Medical, Inc. (2016) Summary page 5.

## Indications for use
The RXiBreeze™ PAP system delivers positive airway pressure therapy for the treatment of obstructive sleep apnea in spontaneously breathing adult patients. It is for single patient use in the home, hospital, or institutional environment.

Source page: https://510kreport.com/device/K253044
Methodology: https://510kreport.com/methodology