Product code BZR
- Device name
- Mixer, Breathing Gases, Anesthesia Inhalation
- Medical specialty
- Anesthesiology
- Device class
- 2
- Regulation number
- 868.5330
- Review panel
- AN
- Implant
- N
- Life sustaining/supporting
- Y
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K243917 | F&P Optiflow Air/Oxygen Flow Source | Fisher & Paykel Healthcare, Ltd. | 2025-07-14 |
| K241465 | Midas Flowmeter; eAVS | Parker Hannifin Corporation | 2024-09-19 |
| K231895 | Maxtec MaxBlend2+p | Maxtec, LLC | 2023-12-04 |
| K230987 | FlowStar Analog Mixer Flowmeter | Baldus Sedation GmbH & Co. KG | 2023-09-14 |
| K222794 | FlowStar Touch Digital Mixer Flowmeter | Baldus Sedation GmbH & Co. KG | 2023-07-28 |
| K221494 | Quality Mix Blender, Oxymixer | Dehas Medical Systems GmbH | 2023-01-23 |
| K202480 | Nitronox Plus 0-70, Nitronox 0-50, Nitronox Plus 50/50 | Parker Hannifin | 2021-04-22 |
| K173205 | Equinox Advantage | O-Two Medical Technologies, Inc. | 2018-08-29 |
| K161718 | MaxBlend 2, MaxBlend Lite | Maxtec, LLC | 2016-10-27 |
| K142291 | GMX Series Medical Air/Oxygen Blender | Gentec (Shanghai) Corporation | 2015-05-19 |
| K113687 | EQUINOX RELIEVE | O-Two Medical Technologies, Inc. | 2012-04-30 |
| K113232 | MAXMIXING BLOCK | Maxtec, Inc. | 2012-03-01 |
| K101286 | SEDARA GAS MIXER, SEDARA SCAVENGER MODEL: 03, 04 | Linde Healthcare AB | 2011-10-20 |
| K103317 | RESUSCITATION UNIT 105 | Atom Medical Corporation | 2011-04-20 |
| K092484 | HELIOX LOW FLOW SENTRY BLENDER | Cardinal Health 207, Inc. | 2010-04-02 |
| K090781 | HELIO2 BLENDER | Precision Medical, Inc. | 2009-08-13 |
| K081335 | TENACORE OXYGEN BLENDER, MODEL TB-2000 | Tenacore Holdings, Inc. | 2008-11-14 |
| K053232 | PRECISION BLENDER | Precision Medical, Inc. | 2006-01-10 |
| K051192 | PRAXAIR MEDICAL AIR MIXER | Praxair, Inc. | 2005-09-06 |
| K050381 | CS MEDICAL TTCF GAS DELIVERY SYSTEM | Cs Medical, Inc. | 2005-07-13 |
| K031860 | SK MED ME202 MONITORING MIXER | Sk Med | 2004-01-21 |
| K031707 | SK MED M201 PLUS MIXER | Sk Med | 2003-08-01 |
| K022864 | SK MED M201 MIXER | Sk Med | 2003-04-11 |
| K001609 | MALLARD AIR OXYGEN ACCUBLENDER | Mallard Medical, Inc. | 2000-08-10 |
| K992503 | SECHRIST AIR-OXYGEN MIXER, 3500/3500HL SERIES | Sechrist Industries, Inc. | 1999-08-10 |
| K990293 | ALADDIN II MONITORING OXYGEN/AIR MONITOR | Hamilton Medical, Inc. | 1999-03-16 |
| K973646 | BIRD SENTRY BLENDER/ ANALYZER / BIRD SENTRY LOW FLOW BLENDER/ANALYZER | Bird Products Corp. | 1998-05-07 |
| K974372 | AIR OXYGE MIXER | Sk Med | 1998-02-05 |
| K960359 | ALADDIN MONITORING OXYGEN/AIR MIXER | Hamilton Medical, Inc. | 1996-04-24 |
| K953711 | AIR ENTRAINER 900RT008 | Fisher & Paykel Electronics , Ltd. | 1995-11-08 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 09420012480347 | F&P Optiflow | FISHER & PAYKEL HEALTHCARE LIMITED | 2025-10-29 |
| 07630002800754 | HAMILTON-T1 | Hamilton Medical AG | 2024-08-21 |
| 07630002813549 | HAMILTON-T1 | Hamilton Medical AG | 2022-01-26 |
| 07630002813532 | HAMILTON-T1 | Hamilton Medical AG | 2022-01-26 |
| 07630002813426 | HAMILTON-C1 | Hamilton Medical AG | 2022-01-26 |
| 10190752156470 | AirLife™ | AIRLIFE | 2021-05-03 |
| 10190752156463 | AirLife™ | VYAIRE MEDICAL, INC. | 2021-05-03 |
| 10190752156449 | AirLife™ | AIRLIFE | 2021-05-03 |
| 10190752156401 | AirLife™ | AIRLIFE | 2021-05-03 |
| 10190752149717 | AirLife™ | AIRLIFE | 2021-05-03 |
| 10190752156494 | AirLife™ | AIRLIFE | 2021-05-03 |
| 07630002806091 | HAMILTON-T1 | Hamilton Medical AG | 2018-08-16 |
| 10846446065053 | BIRD SENTRY2 | Carefusion Corporation | 2017-03-01 |
| 10846446065077 | BIRD SENTRY2 | Carefusion Corporation | 2017-03-01 |
| 10846446065091 | BIRD SENTRY2 | Carefusion Corporation | 2017-03-01 |
| 10846446065114 | BIRD SENTRY2 | Carefusion Corporation | 2017-03-01 |
| 10846446065138 | BIRD SENTRY2 | Carefusion Corporation | 2017-03-01 |
| 10080196003648 | Teleflex/Hudson RCI | MEDLINE INDUSTRIES, INC. | 2016-04-08 |
| 10884389001912 | Teleflex/Hudson RCI | MEDLINE INDUSTRIES, INC. | 2016-04-08 |
| 10884389001677 | Teleflex/Hudson RCI | MEDLINE INDUSTRIES, INC. | 2016-04-08 |
| 10080196986217 | Teleflex/Hudson RCI | MEDLINE INDUSTRIES, INC. | 2016-04-08 |
| 10080196000630 | Teleflex/Hudson RCI | MEDLINE INDUSTRIES, INC. | 2016-04-08 |
| 10885403170317 | AirLife | Carefusion Corporation | 2015-10-24 |
| 10885403170744 | AirLife | Carefusion Corporation | 2015-10-24 |
| 10885403170775 | AirLife | Carefusion Corporation | 2015-10-24 |
| 10885403187223 | AirLife | Carefusion Corporation | 2015-10-24 |
| 10885403187278 | AirLife | Carefusion Corporation | 2015-10-24 |
| 10885403223150 | AirLife | Carefusion Corporation | 2015-10-24 |
| 07630002801850 | HAMILTON-T1 | Hamilton Medical AG | 2015-10-21 |
| 07630002800747 | HAMILTON-C1 | Hamilton Medical AG | 2015-10-21 |