# K100121: Model 300157 Cpap System

- Pathway: 510(k) (Abbreviated)
- Applicant: Aeiomed, Inc.
- Decided: Jul 13, 2010 after 179 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 K903764 (1990). 28 ancestors in all.
5 later devices descend from it; 4 cite it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042945: Aura Cpap System, Aeiomed, Inc. (2005) Summary page 1.
- K042130: Aura Cpap Patient Interface, Aeiomed, Inc. (2004) Summary page 1.
- K052597: Breathex Omega Cpap Device, Model 322, Hoffman Laboratories, LLC (2005) Summary page 2.

## Most influential descendants
- 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
- K140929: Z1 Cpap System (2014), 0 descendants of its own

## Indications for use
The Model 300157 CPAP System is a single patient reusable device. The Model 300157 CPAP System provides continuous positive airway pressure (CPAP) to support treatment of adults (over 30 kg) with Obstructive Sleep Apnea.

Source page: https://510kreport.com/device/K100121
Methodology: https://510kreport.com/methodology