Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart F — Therapeutic Devices](/submissions/AN/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 868.5270](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5270) → BZE — Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer # BZE · Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer _Anesthesiology · 21 CFR 868.5270 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZE ## Overview - **Product Code:** BZE - **Device Name:** Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer - **Regulation:** [21 CFR 868.5270](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5270) - **Device Class:** 2 - **Review Panel:** [Anesthesiology](/submissions/AN) - **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](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZE/K253322.md) | 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](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZE/K243244.md) | Heated Breathing Tube | Guangdong Eda Technology Co., Ltd. | Jul 25, 2025 | SESE | | [K241268](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZE/K241268.md) | Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS) | Exceleron Medical | Aug 2, 2024 | SESE | | [K234032](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZE/K234032.md) | 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](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZE/K222822.md) | VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608) | Draegerwerk AG & CO Kgaa | Jun 14, 2023 | SESE | | [K201418](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZE/K201418.md) | Sunset Heated CPAP Tube | Sunset Healthcare Solutions, Inc. | Jan 29, 2021 | SESE | | [K173280](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZE/K173280.md) | Neonatal ConchaSmart Breathing Circuits | Teleflexmedical, Inc. | Aug 2, 2018 | SESE | | [K170378](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZE/K170378.md) | AirLife Adult Heated Wire BiPAP/NIV Circuit | Vyaire Medical | Sep 14, 2017 | SESE | | [K153234](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZE/K153234.md) | AirLife Adult Heated Wire Circuit | Carefusion, Inc. | Jul 7, 2016 | SESE | | [K160540](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZE/K160540.md) | FLEXICARE NEONATAL HEATED WIRE BREATHING SYSTEM | Flexicare Medical Limited. | Jun 23, 2016 | SESE | | [K151461](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZE/K151461.md) | Hybernite RT | Plastiflex Group NV | Mar 24, 2016 | SESE | | [K151303](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZE/K151303.md) | AirLife Infant Heated Wire Circuit | Care Fusion | Jan 21, 2016 | SESE | | [K151959](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZE/K151959.md) | AirLife Infant Single Limb Heated Wire Circuit | Carefusion, Inc. | Jan 20, 2016 | SESE | | [K150900](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZE/K150900.md) | Flexicare Heated Wire Breathing Systems | Flexicare Medical, Ltd. | May 15, 2015 | SESE | | [K140424](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZE/K140424.md) | RESPIRONICS REUSABLE HEATED TUBING | Respironics, Inc. | Nov 14, 2014 | SESE | | [K122432](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZE/K122432.md) | ADULT EVAQUA 2' DUAL HEATED BREATHING CIRCUITS | Fisher & Paykel Healthcare, Ltd. | Dec 6, 2012 | SESE | | [K103767](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZE/K103767.md) | DUAL HEATED INFANT VREATHING CIROUITS | Fisher & Paykel Healthcare, Ltd. | Apr 16, 2012 | SESE | | [K110398](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZE/K110398.md) | RESPIRONICS DISPOSABLE HEATED WIRE CIRCUITS | Respironics, Inc. | Jun 1, 2011 | SESE | | [K092129](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZE/K092129.md) | INTERSURGICAL HEATED WIRE BREATHING SYSTEMS AND HUMIDIFICATION CHAMBERS, MODEL 2026,2026-CH, 2310, 2320, 2330 | Intersurgical, Inc. | May 18, 2010 | SESE | | [K100104](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZE/K100104.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZE](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZE) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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