# K052597: Breathex Omega Cpap Device, Model 322

- Pathway: 510(k) (Traditional)
- Applicant: Hoffman Laboratories, LLC
- Decided: Dec 16, 2005 after 86 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: 3 generations back to K952292 (1995). 7 ancestors in all.
7 later devices descend from it; 3 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973161: Cpap Humidifier (HC 200), Fisher & Paykel Electronics, Ltd. (1998) Summary page 1.
- K990871: Pillowpositive Cervical Pillow, Lifesleep Systems, Inc. (1999)

## Most influential descendants
- K100121: Model 300157 Cpap System (2010), 5 descendants of its own
- K132127: Transcend Auto (2013), 1 descendant of its own
- K121374: ZI Blower (2013), 1 descendant of its own
- K180388: Transcend 365 miniCPAP System (2018), 0 descendants of its own
- K150365: Cloud9 System (2015), 0 descendants of its own

## Indications for use
The BreatheX Omega CPAP device is intended for treatment of obstructive sleep apnea (OSA) in spontaneously breathing adults weighing at least 30 kg. The BreatheX Omega CPAP device provides continuous positive airway pressure. Caution: Federal law restricts this device to sale by or on the order of a physician.

Source page: https://510kreport.com/device/K052597
Methodology: https://510kreport.com/methodology