# K180388: Transcend 365 miniCPAP System

- Pathway: 510(k) (Traditional)
- Applicant: Somnetics International, Inc.
- Decided: Nov 30, 2018 after 290 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: 9 generations back to K903764 (1990). 43 ancestors in all.
No later device cites it as a predicate yet.
0 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132127: Transcend Auto, Somnetics International, Inc. (2013) Summary page 4.
- K131388: Transcend Heated Humidifier, Somnetics International, Inc. (2013) Summary page 4.

## Indications for use
The ‘Transcend 365 miniCPAP Auto System’ provides positive airway pressure to support treatment of adults over 66 pounds (30 kg) with Obstructive Sleep Apnea (OSA). The device is intended for home and hospital/institutional use. The integrated humidifier provides humidification of air delivered from the Transcend 365 devices. The use of the humidifier is optional.

Source page: https://510kreport.com/device/K180388
Methodology: https://510kreport.com/methodology