Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer

FDA product code BZE · 44 cleared devices

Class 2 Anesthesiology

Regulation: 21 CFR 868.5270
Review panel: AN
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1976-12-30 – 2026-06-18

BZE 2026-06-18

inspired™ Heated Breathing Circuit (510-008); inspired™ Heated Breathing Circuit (510-009); inspired™ Auto-feed Humidification Chamber (VHC10); inspired™ Auto-feed Humidification Chamber (VHC20)

Applicant Vincent Healthcare Products Limited

K number K252066

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BZE 2026-03-25

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)

Applicant Medline Industries, LP

K number K253322

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BZE 2025-07-25

Heated Breathing Tube

Applicant Guangdong Eda Technology Co., Ltd.

K number K243244

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BZE 2024-08-02

Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS)

Applicant Exceleron Medical

K number K241268

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BZE 2024-06-04

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

Applicant Medline Industries, LP

K number K234032

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BZE 2023-06-14

VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608)

Applicant Draegerwerk AG & CO Kgaa

K number K222822

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BZE 2021-01-29

Sunset Heated CPAP Tube

Applicant Sunset Healthcare Solutions, Inc.

K number K201418

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BZE 2018-08-02

Neonatal ConchaSmart Breathing Circuits

Applicant Teleflexmedical, Inc.

K number K173280

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BZE 2017-09-14

AirLife Adult Heated Wire BiPAP/NIV Circuit

Applicant Vyaire Medical

K number K170378

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BZE 2016-07-07

AirLife Adult Heated Wire Circuit

Applicant Carefusion, Inc.

K number K153234

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BZE 2016-06-23

FLEXICARE NEONATAL HEATED WIRE BREATHING SYSTEM

Applicant Flexicare Medical Limited.

K number K160540

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BZE 2016-03-24

Hybernite RT

Applicant Plastiflex Group NV

K number K151461

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BZE 2016-01-21

AirLife Infant Heated Wire Circuit

Applicant Care Fusion

K number K151303

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BZE 2016-01-20

AirLife Infant Single Limb Heated Wire Circuit

Applicant Carefusion, Inc.

K number K151959

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BZE 2012-12-06

ADULT EVAQUA 2' DUAL HEATED BREATHING CIRCUITS

Applicant Fisher & Paykel Healthcare, Ltd.

K number K122432

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BZE 2012-04-16

DUAL HEATED INFANT VREATHING CIROUITS

Applicant Fisher & Paykel Healthcare, Ltd.

K number K103767

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BZE 2011-06-01

RESPIRONICS DISPOSABLE HEATED WIRE CIRCUITS

Applicant Respironics, Inc.

K number K110398

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BZE 2010-05-18

INTERSURGICAL HEATED WIRE BREATHING SYSTEMS AND HUMIDIFICATION CHAMBERS, MODEL 2026,2026-CH, 2310, 2320, 2330

Applicant Intersurgical, Inc.

K number K092129

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BZE 2010-04-14

HYBERNITE RAINOUT CONTROL SYSTEM

Applicant Plastiflex Group NV

K number K100104

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BZE 2005-01-12

RT 138 & RT 141 DUAL-HEATED NEONATAL BREATHING CIRCUITS

Applicant Fisher & Paykel Healthcare, Ltd.

K number K034026

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BZE 2000-03-30

MODIFICATION TO AIRLIFE HEATED VENTILATOR AND ANESTHESIA BREATHING CIRCUITS

Applicant Allegiance Healthcare Corp.

K number K000697

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BZE 1999-12-10

AIRLIFE HEATED VENTILATOR AND BREATHING CIRCUITS

Applicant Allegiance Healthcare Corp.

K number K993833

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BZE 1997-12-02

CRITERION, CRITERION I.V., MODIFIED

Applicant Nova-Ventrx

K number K952267

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BZE 1997-01-14

HEATED WIRE CIRCUITS FOR SCT 3000 HEATED HUMIDIFIER

Applicant Marquest Medical Products, Inc.

K number K962220

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BZE 1993-02-12

HPD HEATER BASES

Applicant Hpd Medical, Inc.

K number K914994

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BZE 1993-01-12

ISOTHERMAL HEATED VENTILATOR & ANESTHESIA CIRCUIT

Applicant Baxter Healthcare Corp

K number K915226

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BZE 1990-08-01

FLEXHTR-1

Applicant Bird Products Corp.

K number K894654

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BZE 1990-01-22

PROTOLOGIC MODEL SER-1

Applicant Protologic, Inc.

K number K894936

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BZE 1988-08-24

BREATHING CIRCUIT W/HEATED WIRE

Applicant Dryden Corp.

K number K880769

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BZE 1988-07-01

DABC NONCONDUCTIVE HEATED ANESTH. BREATH. CIRCUIT

Applicant Intertech Resources, Inc.

K number K881231

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BZE 1988-06-21

CONCHATHERM III PLUS DUAL HEAT WIRE SERVO CONTROLL

Applicant Respiratory Care, Inc.

K number K881625

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BZE 1988-06-10

SIMPLEX UNIVERSAL HEATED TUBING SLEEVE

Applicant Simplex Medical Corp.

K number K881451

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BZE 1988-04-27

VAPOR-PHASE HEATED WIRE CONTROLLER

Applicant Advanced Research Technologies, Inc.

K number K881137

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BZE 1988-03-31

HEATER WIRE BREATHING CIRCUIT

Applicant Life Design Systems, Inc.

K number K873179

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BZE 1986-04-02

DISPOSABLE HEATED WIRE LOOPS 48 AND 72

Applicant Intec Medical, Inc.

K number K860941

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BZE 1985-05-15

ADDITION OF 50% OXYGEN TO APPLINC SAVING BREATH HY

Applicant Applinc

K number K851245

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BZE 1985-01-16

RESPIRATORY GAS HUMIDIFIER

Applicant Applinc

K number K842597

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BZE 1984-11-08

ARM-A-VIAL LV HEATER-BREATHING SYS

Applicant Armour Pharmaceutical Co.

K number K844005

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BZE 1982-09-07

TROPIC AIR HEAT-ECHANGER BREATHING AID

Applicant Tropic Air

K number K821735

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BZE 1980-06-17

ANALOR FOUR-ORAL SURGERY MODEL

Applicant Narco Mckesson Co.

K number K801101

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BZE 1978-11-14

TEMPERATURE CONTROLLER MODEL 17000

Applicant Healthdyne, Inc.

K number K781530

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BZE 1978-05-31

CONTROLLER, SERVO, INSPIRON

Applicant C.R. Bard, Inc.

K number K780630

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BZE 1977-07-05

TA-2 TEMPERATURE ALARM

Applicant Mistogen Equipment Co.

K number K770984

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BZE 1976-12-30

RESP. AIR TEMP. CONTROL & HAZARD MON.

Applicant Harris-Lake, Inc.

K number K761295

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