BZE · Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
Anesthesiology · 21 CFR 868.5270 · Class 2
Overview
| Product Code | BZE |
|---|---|
| Device Name | Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer |
| Regulation | 21 CFR 868.5270 |
| Device Class | Class 2 |
| Review Panel | Anesthesiology |
| 3rd-Party Reviewable | Yes |
Identification
A breathing system heater is a device that is intended to warm breathing gases before they enter a patient's airway. The device may include a temperature controller.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 45)
Showing 20 most recent of 45 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| 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) | Medline Industries, LP | Mar 25, 2026 | SESE |
| K243244 | Heated Breathing Tube | Guangdong Eda Technology Co., Ltd. | Jul 25, 2025 | SESE |
| K241268 | Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS) | Exceleron Medical | Aug 2, 2024 | SESE |
| K234032 | Hudson RCI Dri-Tech Breathing Circuits; HUD99035/Dri-Tech Adult Circuit; HUD99035KIT/Dri-Tech Adult Circuit Kit; HUD99098KIT/Single Limb Adult Dri-Tech Kit; HUD99098KITF/Single Limb Adult Dri-Tech Filter Kit; HUD900/Dri-Tech Ventilator Accessory; HUD901/Dri-Tech Ventilator Accessory Extension Line | Medline Industries, LP | Jun 4, 2024 | SESE |
| K222822 | VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608) | Draegerwerk AG & CO Kgaa | Jun 14, 2023 | SESE |
| K201418 | Sunset Heated CPAP Tube | Sunset Healthcare Solutions, Inc. | Jan 29, 2021 | SESE |
| K173280 | Neonatal ConchaSmart Breathing Circuits | Teleflexmedical, Inc. | Aug 2, 2018 | SESE |
| K170378 | AirLife Adult Heated Wire BiPAP/NIV Circuit | Vyaire Medical | Sep 14, 2017 | SESE |
| K153234 | AirLife Adult Heated Wire Circuit | Carefusion, Inc. | Jul 7, 2016 | SESE |
| K160540 | FLEXICARE NEONATAL HEATED WIRE BREATHING SYSTEM | Flexicare Medical Limited. | Jun 23, 2016 | SESE |
| K151461 | Hybernite RT | Plastiflex Group NV | Mar 24, 2016 | SESE |
| K151303 | AirLife Infant Heated Wire Circuit | Care Fusion | Jan 21, 2016 | SESE |
| K151959 | AirLife Infant Single Limb Heated Wire Circuit | Carefusion, Inc. | Jan 20, 2016 | SESE |
| K150900 | Flexicare Heated Wire Breathing Systems | Flexicare Medical, Ltd. | May 15, 2015 | SESE |
| K140424 | RESPIRONICS REUSABLE HEATED TUBING | Respironics, Inc. | Nov 14, 2014 | SESE |
| K122432 | ADULT EVAQUA 2' DUAL HEATED BREATHING CIRCUITS | Fisher & Paykel Healthcare, Ltd. | Dec 6, 2012 | SESE |
| K103767 | DUAL HEATED INFANT VREATHING CIROUITS | Fisher & Paykel Healthcare, Ltd. | Apr 16, 2012 | SESE |
| K110398 | RESPIRONICS DISPOSABLE HEATED WIRE CIRCUITS | Respironics, Inc. | Jun 1, 2011 | SESE |
| K092129 | INTERSURGICAL HEATED WIRE BREATHING SYSTEMS AND HUMIDIFICATION CHAMBERS, MODEL 2026,2026-CH, 2310, 2320, 2330 | Intersurgical, Inc. | May 18, 2010 | SESE |
| K100104 | HYBERNITE RAINOUT CONTROL SYSTEM | Plastiflex Group NV | Apr 14, 2010 | SESE |
Top Applicants
- Fisher & Paykel Healthcare, Ltd. — 3 clearances
- Allegiance Healthcare Corp. — 2 clearances
- Applinc — 2 clearances
- Carefusion, Inc. — 2 clearances
- Medline Industries, LP — 2 clearances
