# K243244: Heated Breathing Tube

- Pathway: 510(k) (Traditional)
- Applicant: Guangdong Eda Technology Co., Ltd.
- Decided: Jul 25, 2025 after 287 days
- Product code: BZE (Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer)
- Device class: 2
- Regulation: 21 CFR 868.5270
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K914836 (1992). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110860: Comp a-I-R, Omron Healthcare, Inc. (2011) Summary page 5.

## Indications for use
The Heated Breathing Tube is intended to be used for non-invasive respiratory therapy, such as CPAP/BiPAP therapy. It provides air connection between positive pressure ventilation, respiratory humidification therapy instrument, and ventilation mask, nasal cannula, trachea cannula etc. With the function of heating inside breathing tube, it can prevent condensation of the therapy air in the tube. This device is single patient use only for adults.

Source page: https://510kreport.com/device/K243244
Methodology: https://510kreport.com/methodology