Mixer, Breathing Gases, Anesthesia Inhalation

FDA product code BZR · 54 cleared devices

Class 2 Anesthesiology

Regulation: 21 CFR 868.5330
Review panel: AN
Implant: No
Life sustaining: Yes
Third party review: Yes
GMP exempt: No
Clearance span: 1976-07-20 – 2025-07-14

BZR 2025-07-14

F&P Optiflow Air/Oxygen Flow Source

Applicant Fisher & Paykel Healthcare, Ltd.

K number K243917

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BZR 2024-09-19

Midas Flowmeter; eAVS

Applicant Parker Hannifin Corporation

K number K241465

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BZR 2023-12-04

Maxtec MaxBlend2+p

Applicant Maxtec, LLC

K number K231895

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BZR 2023-09-14

FlowStar Analog Mixer Flowmeter

Applicant Baldus Sedation GmbH & Co. KG

K number K230987

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BZR 2023-07-28

FlowStar Touch Digital Mixer Flowmeter

Applicant Baldus Sedation GmbH & Co. KG

K number K222794

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BZR 2023-01-23

Quality Mix Blender, Oxymixer

Applicant Dehas Medical Systems GmbH

K number K221494

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BZR 2021-04-22

Nitronox Plus 0-70, Nitronox 0-50, Nitronox Plus 50/50

Applicant Parker Hannifin

K number K202480

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BZR 2018-08-29

Equinox Advantage

Applicant O-Two Medical Technologies, Inc.

K number K173205

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BZR 2016-10-27

MaxBlend 2, MaxBlend Lite

Applicant Maxtec, LLC

K number K161718

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BZR 2012-04-30

EQUINOX RELIEVE

Applicant O-Two Medical Technologies, Inc.

K number K113687

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BZR 2012-03-01

MAXMIXING BLOCK

Applicant Maxtec, Inc.

K number K113232

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BZR 2011-10-20

SEDARA GAS MIXER, SEDARA SCAVENGER MODEL: 03, 04

Applicant Linde Healthcare AB

K number K101286

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BZR 2011-04-20

RESUSCITATION UNIT 105

Applicant Atom Medical Corporation

K number K103317

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BZR 2010-04-02

HELIOX LOW FLOW SENTRY BLENDER

Applicant Cardinal Health 207, Inc.

K number K092484

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BZR 2009-08-13

HELIO2 BLENDER

Applicant Precision Medical, Inc.

K number K090781

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BZR 2008-11-14

TENACORE OXYGEN BLENDER, MODEL TB-2000

Applicant Tenacore Holdings, Inc.

K number K081335

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BZR 2006-01-10

PRECISION BLENDER

Applicant Precision Medical, Inc.

K number K053232

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BZR 2005-09-06

PRAXAIR MEDICAL AIR MIXER

Applicant Praxair, Inc.

K number K051192

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BZR 2005-07-13

CS MEDICAL TTCF GAS DELIVERY SYSTEM

Applicant Cs Medical, Inc.

K number K050381

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BZR 2004-01-21

SK MED ME202 MONITORING MIXER

Applicant Sk Med

K number K031860

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BZR 2003-08-01

SK MED M201 PLUS MIXER

Applicant Sk Med

K number K031707

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BZR 2003-04-11

SK MED M201 MIXER

Applicant Sk Med

K number K022864

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BZR 2000-08-10

MALLARD AIR OXYGEN ACCUBLENDER

Applicant Mallard Medical, Inc.

K number K001609

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BZR 1999-08-10

SECHRIST AIR-OXYGEN MIXER, 3500/3500HL SERIES

Applicant Sechrist Industries, Inc.

K number K992503

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BZR 1999-03-16

ALADDIN II MONITORING OXYGEN/AIR MONITOR

Applicant Hamilton Medical, Inc.

K number K990293

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BZR 1998-05-07

BIRD SENTRY BLENDER/ ANALYZER / BIRD SENTRY LOW FLOW BLENDER/ANALYZER

Applicant Bird Products Corp.

K number K973646

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BZR 1998-02-05

AIR OXYGE MIXER

Applicant Sk Med

K number K974372

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BZR 1996-04-24

ALADDIN MONITORING OXYGEN/AIR MIXER

Applicant Hamilton Medical, Inc.

K number K960359

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BZR 1995-11-08

AIR ENTRAINER 900RT008

Applicant Fisher & Paykel Electronics , Ltd.

K number K953711

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BZR 1995-09-25

OXY/STAR LOW FLOW BLENDER

Applicant Infrasonics Corp.

K number K952878

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BZR 1995-05-22

PRIMA HYUPERINFLATION SYSTEM

Applicant Prima, Inc.

K number K952021

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BZR 1995-05-11

BABYCARE NEO2 OXYGEN CONCENTRATION CONTROLLER

Applicant Bpr Medical, Ltd.

K number K943797

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BZR 1993-10-07

BMD AIR/OXYGEN BLENDER

Applicant Biomedical Devices, Inc.

K number K925982

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BZR 1993-09-16

MERIDIAN MEDICAL SYSTEMS HYPER INFLATION BAY SYST

Applicant Merit Medical Systems, Inc.

K number K925591

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BZR 1993-07-23

PRECISION MED PRODUCTS LTD HYPERINFLATION SYSTEM

Applicant Precision Med Products, Ltd.

K number K932709

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BZR 1993-07-22

HYPERINFLATION SYSTEM

Applicant Life Shield Healthcare Products, Inc.

K number K932557

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BZR 1991-10-08

BIRD SENTRY AIR/OXYGEN MICROBLENDER

Applicant Bird Products Corp.

K number K911962

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BZR 1990-07-18

LOW FLOW N2O/02O MICROBLENDER

Applicant Bird Products Corp.

K number K900722

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BZR 1990-07-06

BIRD MICROBLENDER M.R.I.

Applicant Bird Products Corp.

K number K895695

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BZR 1989-02-17

NITRONOX(R), FIRST RESPONSE NITRONOX(TM)

Applicant Matrix Medica, Inc.

K number K883833

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BZR 1988-11-16

P/N 9320 LOW FLOW AIR/OXYGEN MICROBLENDER

Applicant Bird Products Corp.

K number K883038

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BZR 1987-09-03

SIEMENS O2-AIR MIXER 965

Applicant Siemens Elema AB

K number K872278

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BZR 1986-06-05

LNI MGV MEDICAL GAS MIXER

Applicant P.A. Mccauley, Inc.

K number K854769

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BZR 1986-05-21

THE M100 AIR/OXYGEN MIXER

Applicant Newport Medical Instruments, Inc.

K number K860373

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BZR 1985-10-16

OHMEDA OXYGEN BLENDER

Applicant Ohmeda Medical

K number K853905

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BZR 1984-07-26

SECHRIST AIR-OXYGEN MIXER & ANCILLARY

Applicant Shiley, Inc.

K number K841789

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BZR 1981-06-09

DOWNS CAP FLOW GENERATOR

Applicant Vital Signs, Inc.

K number K811393

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BZR 1980-09-26

SECHRIST SERIES 3500 AIR-OXYGEN MIXER

Applicant Sechrist Industries, Inc.

K number K802226

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BZR 1980-05-28

ROYAL

Applicant Trident Dental, Inc.

K number K800866

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BZR 1980-05-23

WINDSOR

Applicant Trident Dental, Inc.

K number K800865

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BZR 1980-05-08

SIEMENS-ELEMA AB O2-AIR MIXER 960

Applicant Siemens Elema AB

K number K800905

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BZR 1980-04-29

DRAGER ORMC

Applicant Draeger Medical, Inc.

K number K800764

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BZR 1976-10-08

PRE-SET 50/50 NITROUS OXIDE/OXYGEN MIXER

Applicant Fraser Sweatman, Inc.

K number K760766

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BZR 1976-07-20

CONSIOUS SEDATION (ANALOR P-76)

Applicant Mckesson Corp.

K number K760017

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