# K132127: Transcend Auto

- Pathway: 510(k) (Traditional)
- Applicant: Somnetics International, Inc.
- Decided: Oct 17, 2013 after 99 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: 8 generations back to K903764 (1990). 35 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100121: Model 300157 Cpap System, Aeiomed, Inc. (2010) Summary page 1.
- K041010: Remstar Auto with C-Flex Cpap System, Respironics, Inc. (2004) Summary page 1.

## Most influential descendants
- K180388: Transcend 365 miniCPAP System (2018), 0 descendants of its own

## Indications for use
The Transcend Auto provides positive airway pressure for treatment of obstructive sleep apnea (OSA) in adults weighing over 66 pounds (30 kg). The device is intended for home and hospital/institutional use.

Source page: https://510kreport.com/device/K132127
Methodology: https://510kreport.com/methodology