Product code BZE
- Device name
- Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
- Medical specialty
- Anesthesiology
- Device class
- 2
- Regulation number
- 868.5270
- Review panel
- AN
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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” Inf... | Medline Industries, LP | 2026-03-25 |
| K243244 | Heated Breathing Tube | Guangdong Eda Technology Co., Ltd. | 2025-07-25 |
| K241268 | Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS) | Exceleron Medical | 2024-08-02 |
| 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 A... | Medline Industries, LP | 2024-06-04 |
| K222822 | VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608) | Draegerwerk AG & CO Kgaa | 2023-06-14 |
| K201418 | Sunset Heated CPAP Tube | Sunset Healthcare Solutions, Inc. | 2021-01-29 |
| K173280 | Neonatal ConchaSmart Breathing Circuits | Teleflexmedical, Inc. | 2018-08-02 |
| K170378 | AirLife Adult Heated Wire BiPAP/NIV Circuit | Vyaire Medical | 2017-09-14 |
| K153234 | AirLife Adult Heated Wire Circuit | Carefusion, Inc. | 2016-07-07 |
| K160540 | FLEXICARE NEONATAL HEATED WIRE BREATHING SYSTEM | Flexicare Medical Limited. | 2016-06-23 |
| K151461 | Hybernite RT | Plastiflex Group NV | 2016-03-24 |
| K151303 | AirLife Infant Heated Wire Circuit | Care Fusion | 2016-01-21 |
| K151959 | AirLife Infant Single Limb Heated Wire Circuit | Carefusion, Inc. | 2016-01-20 |
| K150900 | Flexicare Heated Wire Breathing Systems | Flexicare Medical, Ltd. | 2015-05-15 |
| K140424 | RESPIRONICS REUSABLE HEATED TUBING | Respironics, Inc. | 2014-11-14 |
| K122432 | ADULT EVAQUA 2' DUAL HEATED BREATHING CIRCUITS | Fisher & Paykel Healthcare, Ltd. | 2012-12-06 |
| K103767 | DUAL HEATED INFANT VREATHING CIROUITS | Fisher & Paykel Healthcare, Ltd. | 2012-04-16 |
| K110398 | RESPIRONICS DISPOSABLE HEATED WIRE CIRCUITS | Respironics, Inc. | 2011-06-01 |
| K092129 | INTERSURGICAL HEATED WIRE BREATHING SYSTEMS AND HUMIDIFICATION CHAMBERS, MODEL 2026,2026-CH, 2310, 2320, 2330 | Intersurgical, Inc. | 2010-05-18 |
| K100104 | HYBERNITE RAINOUT CONTROL SYSTEM | Plastiflex Group NV | 2010-04-14 |
| K034026 | RT 138 & RT 141 DUAL-HEATED NEONATAL BREATHING CIRCUITS | Fisher & Paykel Healthcare, Ltd. | 2005-01-12 |
| K000697 | MODIFICATION TO AIRLIFE HEATED VENTILATOR AND ANESTHESIA BREATHING CIRCUITS | Allegiance Healthcare Corp. | 2000-03-30 |
| K993833 | AIRLIFE HEATED VENTILATOR AND BREATHING CIRCUITS | Allegiance Healthcare Corp. | 1999-12-10 |
| K952267 | CRITERION, CRITERION I.V., MODIFIED | Nova-Ventrx | 1997-12-02 |
| K962220 | HEATED WIRE CIRCUITS FOR SCT 3000 HEATED HUMIDIFIER | Marquest Medical Products, Inc. | 1997-01-14 |
| K914994 | HPD HEATER BASES | Hpd Medical, Inc. | 1993-02-12 |
| K915226 | ISOTHERMAL HEATED VENTILATOR & ANESTHESIA CIRCUIT | Baxter Healthcare Corp | 1993-01-12 |
| K894654 | FLEXHTR-1 | Bird Products Corp. | 1990-08-01 |
| K894936 | PROTOLOGIC MODEL SER-1 | Protologic, Inc. | 1990-01-22 |
| K880769 | BREATHING CIRCUIT W/HEATED WIRE | Dryden Corp. | 1988-08-24 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 09420012459213 | Fisher & Paykel Healthcare | FISHER & PAYKEL HEALTHCARE LIMITED | 2024-12-23 |
| 09420012453204 | Fisher & Paykel Healthcare | FISHER & PAYKEL HEALTHCARE LIMITED | 2024-12-23 |
| 09420012448422 | Fisher & Paykel Healthcare | FISHER & PAYKEL HEALTHCARE LIMITED | 2024-12-23 |
| 09420012456601 | Fisher & Paykel Healthcare | FISHER & PAYKEL HEALTHCARE LIMITED | 2022-08-02 |
| 09420012431080 | Fisher & Paykel Healthcare | FISHER & PAYKEL HEALTHCARE LIMITED | 2022-08-02 |
| 09420012432162 | Fisher & Paykel Healthcare | FISHER & PAYKEL HEALTHCARE LIMITED | 2022-08-02 |
| 09420012431165 | Fisher & Paykel Healthcare | FISHER & PAYKEL HEALTHCARE LIMITED | 2022-08-02 |
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| 10190752153011 | AirLife™ | AIRLIFE | 2021-05-07 |
| 10190752152113 | AirLife™ | AIRLIFE | 2021-04-02 |
| 10190752152984 | AirLife™ | AIRLIFE | 2021-04-02 |
| 10190752151833 | AirLife™ | AIRLIFE | 2021-04-02 |
| 10190752151802 | AirLife™ | AIRLIFE | 2021-04-02 |
| 10190752148215 | AirLife™ | AIRLIFE | 2021-04-02 |
| 10190752151857 | AirLife™ | AIRLIFE | 2021-03-26 |
| 10190752145108 | AirLife™ | AIRLIFE | 2020-01-15 |
| 10190752145146 | AirLife™ | AIRLIFE | 2020-01-15 |
| 10190752145139 | AirLife™ | AIRLIFE | 2020-01-15 |
| 10190752145115 | AirLife™ | AIRLIFE | 2020-01-15 |
| 10190752134133 | AirLife™ | AIRLIFE | 2019-12-20 |
| 09420012429728 | F&P Evaqua 2 | FISHER & PAYKEL HEALTHCARE LIMITED | 2016-09-08 |
| 09420012431103 | F&P Evaqua 2 | FISHER & PAYKEL HEALTHCARE LIMITED | 2016-09-08 |
| 09420012431097 | Fisher & Paykel Healthcare | FISHER & PAYKEL HEALTHCARE LIMITED | 2016-09-08 |
| 09420012431059 | Fisher & Paykel Healthcare | FISHER & PAYKEL HEALTHCARE LIMITED | 2016-09-08 |
| 09420012430472 | F&P Evaqua 2 | FISHER & PAYKEL HEALTHCARE LIMITED | 2016-09-08 |
| 09420012430373 | Fisher & Paykel Healthcare | FISHER & PAYKEL HEALTHCARE LIMITED | 2016-09-08 |
| 09420012430205 | F&P Evaqua 2 | FISHER & PAYKEL HEALTHCARE LIMITED | 2016-09-08 |