# K201418: Sunset Heated CPAP Tube

- Pathway: 510(k) (Traditional)
- Applicant: Sunset Healthcare Solutions, Inc.
- Decided: Jan 29, 2021 after 245 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: 8 generations back to K952292 (1995). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140424: Respironics Reusable Heated Tubing, Respironics, Inc. (2014) Summary page 4.

## Indications for use
The Sunset Heated CPAP Tube 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 in clinical settings, such as hospitals, institutions, sleep laboratories, and sub-acute care facilities. It may be used with non-invasive ventilation for adult patients. It is compatible with the Philips Respironics System One Heated Humidifier and Philips Respironics Dreamstation Heated Humidifier.

Source page: https://510kreport.com/device/K201418
Methodology: https://510kreport.com/methodology