# K100104: Hybernite Rainout Control System

- Pathway: 510(k) (Traditional)
- Applicant: Plastiflex Group NV
- Decided: Apr 14, 2010 after 91 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: 5 generations back to K952292 (1995). 11 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071958: Thera-Heat Heated Humidifier and  Adult Dual and Single Limb Heated Wire Ventilator Breathing Circuits, Smiths Medical Asd, Inc. (2007) Summary page 1.
- K041900: HC604 Cpap Humidifier, Fisher & Paykel Healthcare, Ltd. (2004) Summary page 1.

## Most influential descendants
- K110398: Respironics Disposable Heated Wire Circuits (2011), 3 descendants of its own
- K140424: Respironics Reusable Heated Tubing (2014), 2 descendants of its own
- K122705: Humicare D900 (2013), 1 descendant of its own
- 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 Hybernite Rainout Control System is a heated breathing circuit intended to provide warmed and/or humidified breathing gases before entering the patient airway. The Hybernite device is intended for incorporation into OPAP (continuous positive airway pressure) devices and is intended to act as a conduit for the breathing gasses delivered from the humidifier to the patient. After the gas is warmed and humidified in the humidifier, it is delivered through the heated tubing to the patient. The purpose of the Hybenite Rainout Control System is to maintain or raise the gas temperature to or above the dew point (of the air exiting the humidifier) reducing or eliminating water condensation and/or pooling of water in the breathing circuit, and problems associated with such. The Hybernite Rainout Control System is indicated for use in the home or sleep-lab setting by a single adult patient. It can also be used in conjunction with supplemental Oxygen. The Hybernite Rainout Control System is indicated for non-invasive ventilation.

Source page: https://510kreport.com/device/K100104
Methodology: https://510kreport.com/methodology