Atlas FDA

BZR

55 FDA 510(k) clearances · Product code

120 daysmedian time to decision
288 days90th percentile
55clearances measured

FDA profile

Official device name
Mixer, Breathing Gases, Anesthesia Inhalation
Device class
Class II (moderate risk)
Regulation
21 CFR 868.5330
Medical specialty
Anesthesiology
Flags
Life-sustaining · Third-party review eligible
Adverse events (MAUDE)
2019: 26 · 2020: 15 · 2021: 33 · 2022: 15 · 2023: 19 · 2024: 18
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
F&P Optiflow Air/Oxygen Flow Source (K243917)Fisher & Paykel Healthcare, Ltd.2025-07-14
Midas Flowmeter; eAVS (K241465)Parker Hannifin Corporation2024-09-19
Maxtec MaxBlend2+p (K231895)Maxtec, LLC2023-12-04
FlowStar Analog Mixer Flowmeter (K230987)Baldus Sedation GmbH & Co. KG2023-09-14
FlowStar Touch Digital Mixer Flowmeter (K222794)Baldus Sedation GmbH & Co. KG2023-07-28
Quality Mix Blender, Oxymixer (K221494)Dehas Medical Systems GmbH2023-01-23
Nitronox Plus 0-70, Nitronox 0-50, Nitronox Plus 50/50 (K202480)Parker Hannifin2021-04-22
Equinox Advantage (K173205)O-Two Medical Technologies, Inc.2018-08-29
MaxBlend 2, MaxBlend Lite (K161718)Maxtec, LLC2016-10-27
GMX Series Medical Air/Oxygen Blender (K142291)Gentec (Shanghai) Corporation2015-05-19
EQUINOX RELIEVE (K113687)O-Two Medical Technologies, Inc.2012-04-30
MAXMIXING BLOCK (K113232)Maxtec, Inc.2012-03-01
SEDARA GAS MIXER, SEDARA SCAVENGER MODEL: 03, 04 (K101286)Linde Healthcare AB2011-10-20
RESUSCITATION UNIT 105 (K103317)Atom Medical Corporation2011-04-20
HELIOX LOW FLOW SENTRY BLENDER (K092484)Cardinal Health 207, Inc.2010-04-02
HELIO2 BLENDER (K090781)Precision Medical, Inc.2009-08-13
TENACORE OXYGEN BLENDER, MODEL TB-2000 (K081335)Tenacore Holdings, Inc.2008-11-14
PRECISION BLENDER (K053232)Precision Medical, Inc.2006-01-10
PRAXAIR MEDICAL AIR MIXER (K051192)Praxair, Inc.2005-09-06
CS MEDICAL TTCF GAS DELIVERY SYSTEM (K050381)Cs Medical, Inc.2005-07-13
SK MED ME202 MONITORING MIXER (K031860)Sk Med2004-01-21
SK MED M201 PLUS MIXER (K031707)Sk Med2003-08-01
SK MED M201 MIXER (K022864)Sk Med2003-04-11
MALLARD AIR OXYGEN ACCUBLENDER (K001609)Mallard Medical, Inc.2000-08-10
SECHRIST AIR-OXYGEN MIXER, 3500/3500HL SERIES (K992503)Sechrist Industries, Inc.1999-08-10
ALADDIN II MONITORING OXYGEN/AIR MONITOR (K990293)Hamilton Medical, Inc.1999-03-16
BIRD SENTRY BLENDER/ ANALYZER / BIRD SENTRY LOW FLOW BLENDER/ANALYZER (K973646)Bird Products Corp.1998-05-07
AIR OXYGE MIXER (K974372)Sk Med1998-02-05
ALADDIN MONITORING OXYGEN/AIR MIXER (K960359)Hamilton Medical, Inc.1996-04-24
AIR ENTRAINER 900RT008 (K953711)Fisher & Paykel Electronics , Ltd.1995-11-08
OXY/STAR LOW FLOW BLENDER (K952878)Infrasonics Corp.1995-09-25
PRIMA HYUPERINFLATION SYSTEM (K952021)Prima, Inc.1995-05-22
BABYCARE NEO2 OXYGEN CONCENTRATION CONTROLLER (K943797)Bpr Medical, Ltd.1995-05-11
BMD AIR/OXYGEN BLENDER (K925982)Biomedical Devices, Inc.1993-10-07
MERIDIAN MEDICAL SYSTEMS HYPER INFLATION BAY SYST (K925591)Merit Medical Systems, Inc.1993-09-16
PRECISION MED PRODUCTS LTD HYPERINFLATION SYSTEM (K932709)Precision Med Products, Ltd.1993-07-23
HYPERINFLATION SYSTEM (K932557)Life Shield Healthcare Products, Inc.1993-07-22
BIRD SENTRY AIR/OXYGEN MICROBLENDER (K911962)Bird Products Corp.1991-10-08
LOW FLOW N2O/02O MICROBLENDER (K900722)Bird Products Corp.1990-07-18
BIRD MICROBLENDER M.R.I. (K895695)Bird Products Corp.1990-07-06
NITRONOX(R), FIRST RESPONSE NITRONOX(TM) (K883833)Matrix Medica, Inc.1989-02-17
P/N 9320 LOW FLOW AIR/OXYGEN MICROBLENDER (K883038)Bird Products Corp.1988-11-16
SIEMENS O2-AIR MIXER 965 (K872278)Siemens Elema AB1987-09-03
LNI MGV MEDICAL GAS MIXER (K854769)P.A. Mccauley, Inc.1986-06-05
THE M100 AIR/OXYGEN MIXER (K860373)Newport Medical Instruments, Inc.1986-05-21
OHMEDA OXYGEN BLENDER (K853905)Ohmeda Medical1985-10-16
SECHRIST AIR-OXYGEN MIXER & ANCILLARY (K841789)Shiley, Inc.1984-07-26
DOWNS CAP FLOW GENERATOR (K811393)Vital Signs, Inc.1981-06-09
SECHRIST SERIES 3500 AIR-OXYGEN MIXER (K802226)Sechrist Industries, Inc.1980-09-26
ROYAL (K800866)Trident Dental, Inc.1980-05-28
WINDSOR (K800865)Trident Dental, Inc.1980-05-23
SIEMENS-ELEMA AB O2-AIR MIXER 960 (K800905)Siemens Elema AB1980-05-08
DRAGER ORMC (K800764)Draeger Medical, Inc.1980-04-29
PRE-SET 50/50 NITROUS OXIDE/OXYGEN MIXER (K760766)Fraser Sweatman, Inc.1976-10-08
CONSIOUS SEDATION (ANALOR P-76) (K760017)Mckesson Corp.1976-07-20

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Every clearance here is in the API, with alerts when new ones post.