# K042945: Aura Cpap System

- Pathway: 510(k) (Abbreviated)
- Applicant: Aeiomed, Inc.
- Decided: Mar 9, 2005 after 135 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: 6 generations back to K903764 (1990). 15 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030985: Breas PV 10I Cpap System, Model PV 10I, Vital Signs, Inc. (2003) Summary page 1.
- K010263: Remstar Plus Cpap System, Respironics, Inc. (2001) Summary page 1.

## 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 aura CPAP System provides continuous positive airway pressure (CPAP) to support treatment of adults (over 30kg) with Obstructive Sleep Apnea.

Source page: https://510kreport.com/device/K042945
Methodology: https://510kreport.com/methodology