BZR · Class II · 21 CFR 868.5330

FDA Product Code BZR: Mixer, Breathing Gases, Anesthesia Inhalation

Leading manufacturers include Bird Products Corp., Sk Med and Baldus Sedation GmbH & Co. KG.

55
Total
55
Cleared
142d
Avg days
1976
Since
Declining activity - 1 submissions in the last 2 years vs 5 in the prior period
Review times increasing: avg 206d recently vs 141d historically

FDA 510(k) Cleared Mixer, Breathing Gases, Anesthesia Inhalation Devices (Product Code BZR)

55 devices
1–24 of 55
Cleared Jul 14, 2025
F&P Optiflow Air/Oxygen Flow Source
K243917
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 206d
Cleared Sep 19, 2024
Midas Flowmeter
K241465
Parker Hannifin Corporation
Anesthesiology · 119d
Cleared Dec 04, 2023
Maxtec MaxBlend2+p
K231895
Maxtec, LLC
Anesthesiology · 159d
Cleared Sep 14, 2023
FlowStar Analog Mixer Flowmeter
K230987
Baldus Sedation GmbH & Co. KG
Anesthesiology · 161d
Cleared Jul 28, 2023
FlowStar Touch Digital Mixer Flowmeter
K222794
Baldus Sedation GmbH & Co. KG
Anesthesiology · 315d
Cleared Jan 23, 2023
Quality Mix Blender, Oxymixer
K221494
Dehas Medical Systems GmbH
Anesthesiology · 245d
Cleared Apr 22, 2021
Nitronox Plus 0-70, Nitronox 0-50, Nitronox Plus 50/50
K202480
Parker Hannifin
Anesthesiology · 237d
Cleared Aug 29, 2018
Equinox Advantage
K173205
O-Two Medical Technologies, Inc.
Anesthesiology · 331d
Cleared Oct 27, 2016
MaxBlend 2, MaxBlend Lite
K161718
Maxtec, LLC
Anesthesiology · 127d
Cleared May 19, 2015
GMX Series Medical Air/Oxygen Blender
K142291
Gentec (Shanghai) Corporation
Anesthesiology · 274d
Cleared Apr 30, 2012
EQUINOX RELIEVE
K113687
O-Two Medical Technologies, Inc.
Anesthesiology · 137d
Cleared Mar 01, 2012
MAXMIXING BLOCK
K113232
Maxtec, Inc.
Anesthesiology · 120d
Cleared Oct 20, 2011
SEDARA GAS MIXER, SEDARA SCAVENGER MODEL: 03, 04
K101286
Linde Healthcare AB
Anesthesiology · 531d
Cleared Apr 20, 2011
RESUSCITATION UNIT 105
K103317
Atom Medical Corporation
Anesthesiology · 161d
Cleared Apr 02, 2010
HELIOX LOW FLOW SENTRY BLENDER
K092484
Cardinal Health 207, Inc.
Anesthesiology · 232d
Cleared Aug 13, 2009
HELIO2 BLENDER
K090781
Precision Medical, Inc.
Anesthesiology · 143d
Cleared Nov 14, 2008
TENACORE OXYGEN BLENDER, MODEL TB-2000
K081335
Tenacore Holdings, Inc.
Anesthesiology · 186d
Cleared Jan 10, 2006
PRECISION BLENDER
K053232
Precision Medical, Inc.
Anesthesiology · 53d
Cleared Sep 06, 2005
PRAXAIR MEDICAL AIR MIXER
K051192
Praxair, Inc.
Anesthesiology · 119d
Cleared Jul 13, 2005
CS MEDICAL TTCF GAS DELIVERY SYSTEM
K050381
Cs Medical, Inc.
Anesthesiology · 148d
Cleared Jan 21, 2004
SK MED ME202 MONITORING MIXER
K031860
Sk Med
Anesthesiology · 219d
Cleared Aug 01, 2003
SK MED M201 PLUS MIXER
K031707
Sk Med
Anesthesiology · 60d
Cleared Apr 11, 2003
SK MED M201 MIXER
K022864
Sk Med
Anesthesiology · 226d
Cleared Aug 10, 2000
MALLARD AIR OXYGEN ACCUBLENDER
K001609
Mallard Medical, Inc.
Anesthesiology · 78d

About Product Code BZR - Regulatory Context

510(k) Submission Activity

55 total 510(k) submissions under product code BZR since 1976, with 55 receiving FDA clearance (average review time: 142 days).

Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 5 in the prior period.

FDA 510(k) Review Time - BZR Product Code

Recent submissions under BZR have taken an average of 206 days to reach a decision - up from 141 days historically. Manufacturers should account for longer review timelines in current project planning.

BZR devices are reviewed by the Anesthesiology panel. Browse all Anesthesiology devices →