# K131388: Transcend Heated Humidifier

- Pathway: 510(k) (Traditional)
- Applicant: Somnetics International, Inc.
- Decided: Sep 26, 2013 after 135 days
- Product code: BTT (Humidifier, Respiratory Gas, (Direct Patient Interface))
- Device class: 2
- Regulation: 21 CFR 868.5450
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K974417 (1998). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080797: Humidaire 2I, Resmed, Ltd. (2008) Summary page 4.

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

## Indications for use
The Transcend Heated Humidifier is indicated for the humidification of the air delivered from a compatible Transcend positive airway pressure therapy device. The Humidifier is intended for single patient re-use in the home environment and in a hospital/institutional environment. The Humidifier is for use only as recommended by a physician.

Source page: https://510kreport.com/device/K131388
Methodology: https://510kreport.com/methodology