# K110398: Respironics Disposable Heated Wire Circuits

- Pathway: 510(k) (Abbreviated)
- Applicant: Respironics, Inc.
- Decided: Jun 1, 2011 after 110 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: 6 generations back to K952292 (1995). 20 ancestors in all.
3 later devices descend from it; 1 cites 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)
- K100104: Hybernite Rainout Control System, Plastiflex Group NV (2010) Summary page 2.
- K092129: Intersurgical Heated Wire Breathing Systems and Humidification Chambers, Model 2026,2026-CH, 2310, 2320, 2330, Intersurgical, Inc. (2010) Summary page 2.
- K983112: Respiratory Humidifier, Model # MR850, Fisher & Paykel Healthcare, Ltd. (1998) Summary page 2.

## Most influential descendants
- K140424: Respironics Reusable Heated Tubing (2014), 2 descendants 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 disposable heated wire circuit is a heated wire breathing circuit intended to provide warmed and/or humidified breathing gases before they enter a patient's airway. The disposable heated wire circuit is indicated for use by a single adult or pediatric patient in the home, hospital and/or institutional settings. It may be used for both invasive and non-invasive ventilation.

Source page: https://510kreport.com/device/K110398
Methodology: https://510kreport.com/methodology