Panels › Anesthesiology › Product code BZR · Class 2
Mixer, Breathing Gases, Anesthesia Inhalation
Regulation 868.5330
0510(k)s in 12 months (55 all time)
0recalls in 12 months (3 all time)
3recalls that name a 510(k)
Top companies in BZR
| Company | 510(k)s | Recalls |
|---|---|---|
| Bird Products Corp. | 5 | 0 |
| Sk Med | 4 | 0 |
| Maxtec, Inc. | 3 | 0 |
| O-Two Medical Technologies, Inc. | 2 | 1 |
| Baldus Sedation GmbH & Co. KG | 2 | 0 |
| Hamilton Medical, Inc. | 2 | 0 |
| Parker Hannifin | 2 | 0 |
| Precision Medical, Inc. | 2 | 0 |
| Sechrist Industries, Inc. | 2 | 0 |
| Siemens Elema AB | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 14, 2025 | K243917 | F&P Optiflow Air/Oxygen Flow Source Fisher & Paykel Healthcare, Ltd., NZ | BZR |
| Sep 19, 2024 | K241465 | Midas Flowmeter; eAVS Parker Hannifin Corporation | BZR |
| Dec 4, 2023 | K231895 | Maxtec MaxBlend2+p Maxtec, LLC | BZR |
| Sep 14, 2023 | K230987 | FlowStar Analog Mixer Flowmeter Baldus Sedation GmbH & Co. KG, DE | BZR |
| Jul 28, 2023 | K222794 | FlowStar Touch Digital Mixer Flowmeter Baldus Sedation GmbH & Co. KG, DE | BZR |
| Jan 23, 2023 | K221494 | Quality Mix Blender, Oxymixer Dehas Medical Systems GmbH, DE | BZR |
| Apr 22, 2021 | K202480 | Nitronox Plus 0-70, Nitronox 0-50, Nitronox Plus 50/50 Parker Hannifin | BZR |
| Aug 29, 2018 | K173205 | Equinox Advantage O-Two Medical Technologies, Inc., CA | BZR |
| Oct 27, 2016 | K161718 | MaxBlend 2, MaxBlend Lite Maxtec, LLC | BZR |
| May 19, 2015 | K142291 | GMX Series Medical Air/Oxygen Blender Gentec (Shanghai) Corporation, CN | BZR |
| Apr 30, 2012 | K113687 | EQUINOX RELIEVE O-Two Medical Technologies, Inc., CA | BZR |
| Mar 1, 2012 | K113232 | MAXMIXING BLOCK Maxtec, Inc. | BZR |
| Oct 20, 2011 | K101286 | SEDARA GAS MIXER, SEDARA SCAVENGER MODEL: 03, 04 Linde Healthcare AB, SE | BZR |
| Apr 20, 2011 | K103317 | RESUSCITATION UNIT 105 Atom Medical Corporation | BZR |
| Apr 2, 2010 | K092484 | HELIOX LOW FLOW SENTRY BLENDER Cardinal Health 207, Inc. | BZR |
| Aug 13, 2009 | K090781 | HELIO2 BLENDER Precision Medical, Inc. | BZR |
| Nov 14, 2008 | K081335 | TENACORE OXYGEN BLENDER, MODEL TB-2000 Tenacore Holdings, Inc. | BZR |
| Jan 10, 2006 | K053232 | PRECISION BLENDER Precision Medical, Inc. | BZR |
| Sep 6, 2005 | K051192 | PRAXAIR MEDICAL AIR MIXER Praxair, Inc. | BZR |
| Jul 13, 2005 | K050381 | CS MEDICAL TTCF GAS DELIVERY SYSTEM Cs Medical, Inc. | BZR |
| Jan 21, 2004 | K031860 | SK MED ME202 MONITORING MIXER Sk Med | BZR |
| Aug 1, 2003 | K031707 | SK MED M201 PLUS MIXER Sk Med | BZR |
| Apr 11, 2003 | K022864 | SK MED M201 MIXER Sk Med | BZR |
| Aug 10, 2000 | K001609 | MALLARD AIR OXYGEN ACCUBLENDER Mallard Medical, Inc. | BZR |
| Aug 10, 1999 | K992503 | SECHRIST AIR-OXYGEN MIXER, 3500/3500HL SERIES Sechrist Industries, Inc. | BZR |
| Mar 16, 1999 | K990293 | ALADDIN II MONITORING OXYGEN/AIR MONITOR Hamilton Medical, Inc. | BZR |
| May 7, 1998 | K973646 | BIRD SENTRY BLENDER/ ANALYZER / BIRD SENTRY LOW FLOW BLENDER/ANALYZER Bird Products Corp. | BZR |
| Feb 5, 1998 | K974372 | AIR OXYGE MIXER Sk Med | BZR |
| Apr 24, 1996 | K960359 | ALADDIN MONITORING OXYGEN/AIR MIXER Hamilton Medical, Inc. | BZR |
| Nov 8, 1995 | K953711 | AIR ENTRAINER 900RT008 Fisher & Paykel Electronics , Ltd., NZ | BZR |
| Sep 25, 1995 | K952878 | OXY/STAR LOW FLOW BLENDER Infrasonics Corp. | BZR |
| May 22, 1995 | K952021 | PRIMA HYUPERINFLATION SYSTEM Prima, Inc. | BZR |
| May 11, 1995 | K943797 | BABYCARE NEO2 OXYGEN CONCENTRATION CONTROLLER Bpr Medical, Ltd., GB | BZR |
| Oct 7, 1993 | K925982 | BMD AIR/OXYGEN BLENDER Biomedical Devices, Inc. | BZR |
| Sep 16, 1993 | K925591 | MERIDIAN MEDICAL SYSTEMS HYPER INFLATION BAY SYST Merit Medical Systems, Inc. | BZR |
| Jul 23, 1993 | K932709 | PRECISION MED PRODUCTS LTD HYPERINFLATION SYSTEM Precision Med Products, Ltd. | BZR |
| Jul 22, 1993 | K932557 | HYPERINFLATION SYSTEM Life Shield Healthcare Products, Inc. | BZR |
| Oct 8, 1991 | K911962 | BIRD SENTRY AIR/OXYGEN MICROBLENDER Bird Products Corp. | BZR |
| Jul 18, 1990 | K900722 | LOW FLOW N2O/02O MICROBLENDER Bird Products Corp. | BZR |
| Jul 6, 1990 | K895695 | BIRD MICROBLENDER M.R.I. Bird Products Corp. | BZR |
| Feb 17, 1989 | K883833 | NITRONOX(R), FIRST RESPONSE NITRONOX(TM) Matrix Medica, Inc. | BZR |
| Nov 16, 1988 | K883038 | P/N 9320 LOW FLOW AIR/OXYGEN MICROBLENDER Bird Products Corp. | BZR |
| Sep 3, 1987 | K872278 | SIEMENS O2-AIR MIXER 965 Siemens Elema AB | BZR |
| Jun 5, 1986 | K854769 | LNI MGV MEDICAL GAS MIXER P.A. Mccauley, Inc. | BZR |
| May 21, 1986 | K860373 | THE M100 AIR/OXYGEN MIXER Newport Medical Instruments, Inc. | BZR |
| Oct 16, 1985 | K853905 | OHMEDA OXYGEN BLENDER Ohmeda Medical | BZR |
| Jul 26, 1984 | K841789 | SECHRIST AIR-OXYGEN MIXER & ANCILLARY Shiley, Inc. | BZR |
| Jun 9, 1981 | K811393 | DOWNS CAP FLOW GENERATOR Vital Signs, Inc. | BZR |
| Sep 26, 1980 | K802226 | SECHRIST SERIES 3500 AIR-OXYGEN MIXER Sechrist Industries, Inc. | BZR |
| May 28, 1980 | K800866 | ROYAL Trident Dental, Inc. | BZR |
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