# K092129: Intersurgical Heated Wire Breathing Systems and Humidification Chambers, Model 2026,2026-CH, 2310, 2320, 2330

- Pathway: 510(k) (Traditional)
- Applicant: Intersurgical, Inc.
- Decided: May 18, 2010 after 307 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: 1 generation back to K850647 (1985). 2 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K850647: Heated Respiratory Humififier MR440, Fisher & Paykel Allied Products, Ltd. (1985) Summary page 5.
- K862923: MR620 Dual Servo Heated Anaesthesia Humidifier, Fisher & Paykel Allied Products, Ltd. (1986) Summary page 7.
- (no number) Fisher & Paykel RT2100 dual wire heated breathing circuit: named in the summary without a submission number
- (no number) Fisher & Paykel MR 290 Autofeed Humidification Chamber: named in the summary without a submission number

## Most influential descendants
- K110398: Respironics Disposable Heated Wire Circuits (2011), 3 descendants of its own
- K151461: Hybernite RT (2016), 2 descendants of its own
- K140424: Respironics Reusable Heated Tubing (2014), 2 descendants of its own
- K253322: Hudson RCI® Infant Dri-TechTM Breathing Circuits (HUD99060 / Dri-Tech with 78” Infant Circuit, HUD99060KIT / Dri-Tech with 78” Infant Circuit Kit, HUD99001KIT / Single Limb Infant Circuit Dri-Tech Kit, HUD99009KIT / Dri-Tech with 60” Infant Circuit Kit, HUD99018KIT / Dri-Tech with 44” Infant Circuit Kit, HUD870NKIT / Dri-Tech Infant Accessory Bag, HUD1631 / Infant Wye Connector with Swivel) (2026), 0 descendants of its own
- K241268: Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS) (2024), 0 descendants of its own

## Indications for use
Breathing system heaters are defined as a device that is intended to warm breathing gases before they enter a patient's airway. Humidification chambers are intended for use to hold water required to humidify the air being delivered to patients.

Source page: https://510kreport.com/device/K092129
Methodology: https://510kreport.com/methodology