# K140424: Respironics Reusable Heated Tubing

- Pathway: 510(k) (Traditional)
- Applicant: Respironics, Inc.
- Decided: Nov 14, 2014 after 268 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: 7 generations back to K952292 (1995). 21 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110398: Respironics Disposable Heated Wire Circuits, Respironics, Inc. (2011) Summary page 4.

## Most influential descendants
- K241268: Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS) (2024), 0 descendants of its own
- K201418: Sunset Heated CPAP Tube (2021), 0 descendants of its own

## Indications for use
The Philips Respironics Reusable Heated Tubing is a heated wire breathing tube intended to provide warmed and/or humidified breathing gases before they enter a patient's airway. It is indicated for single-patient reuse in the home and multi-patient use in clinical settings, such as hospitals, institutions, sleep laboratories, and sub-acute care facilities. It may be used with non-invasive ventilation for patients weighing over 10 kg (22lbs). It is compatible with the Philips Respironics System One Heated Humidifier and Philips Respironics A-Series System One Heated Humidifier.

Source page: https://510kreport.com/device/K140424
Methodology: https://510kreport.com/methodology