FDA 510(k) Applications for Medical Device Product Code "BZE"
(Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K993833 | ALLEGIANCE HEALTHCARE CORP. | AIRLIFE HEATED VENTILATOR AND BREATHING CIRCUITS | 12/10/1999 |
| K000697 | ALLEGIANCE HEALTHCARE CORP. | MODIFICATION TO AIRLIFE HEATED VENTILATOR AND ANESTHESIA BREATHING CIRCUITS | 03/30/2000 |
| K151303 | CAREFUSION | AirLife Infant Heated Wire Circuit | 01/21/2016 |
| K153234 | CAREFUSION INC | AirLife Adult Heated Wire Circuit | 07/07/2016 |
| K151959 | CAREFUSION INC | AirLife Infant Single Limb Heated Wire Circuit | 01/20/2016 |
| K222822 | Draegerwerk AG & Co. KGaA | VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608) | 06/14/2023 |
| K241268 | Exceleron Medical | Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS) | 08/02/2024 |
| K103767 | FISHER & PAYKEL HEALTHCARE LTD. | DUAL HEATED INFANT VREATHING CIROUITS | 04/16/2012 |
| K122432 | FISHER & PAYKEL HEALTHCARE, LTD. | ADULT EVAQUA 2' DUAL HEATED BREATHING CIRCUITS | 12/06/2012 |
| K034026 | FISHER & PAYKEL HEALTHCARE, LTD. | RT 138 & RT 141 DUAL-HEATED NEONATAL BREATHING CIRCUITS | 01/12/2005 |
| K160540 | FLEXICARE MEDICAL LIMITED | FLEXICARE NEONATAL HEATED WIRE BREATHING SYSTEM | 06/23/2016 |
| K150900 | FLEXICARE MEDICAL LTD. | Flexicare Heated Wire Breathing Systems | 05/15/2015 |
| K243244 | GuangDong EDA Technology Co., Ltd | Heated Breathing Tube | 07/25/2025 |
| K092129 | INTERSURGICAL, INC. | INTERSURGICAL HEATED WIRE BREATHING SYSTEMS AND HUMIDIFICATION CHAMBERS, MODEL 2026,2026-CH, 2310, 2320, 2330 | 05/18/2010 |
| K962220 | MARQUEST MEDICAL PRODUCTS, INC. | HEATED WIRE CIRCUITS FOR SCT 3000 HEATED HUMIDIFIER | 01/14/1997 |
| K234032 | Medline Industries, LP | 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/D | 06/04/2024 |
| K952267 | NOVA-VENTRX | CRITERION, CRITERION I.V., MODIFIED | 12/02/1997 |
| K100104 | PLASTIFLEX GROUP NV | HYBERNITE RAINOUT CONTROL SYSTEM | 04/14/2010 |
| K151461 | PLASTIFLEX GROUP NV | Hybernite RT | 03/24/2016 |
| K110398 | RESPIRONICS, INC. | RESPIRONICS DISPOSABLE HEATED WIRE CIRCUITS | 06/01/2011 |
| K140424 | RESPIRONICS, INC. | RESPIRONICS REUSABLE HEATED TUBING | 11/14/2014 |
| K201418 | Sunset Healthcare Solutions, Inc. | Sunset Heated CPAP Tube | 01/29/2021 |
| K173280 | Teleflex Medical, Inc | Neonatal ConchaSmart Breathing Circuits | 08/02/2018 |
| K170378 | Vyaire Medical | AirLife Adult Heated Wire BiPAP/NIV Circuit | 09/14/2017 |
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