BZR · Mixer, Breathing Gases, Anesthesia Inhalation
Anesthesiology · 21 CFR 868.5330 · Class 2
Overview
| Product Code | BZR |
|---|---|
| Device Name | Mixer, Breathing Gases, Anesthesia Inhalation |
| Regulation | 21 CFR 868.5330 |
| Device Class | Class 2 |
| Review Panel | Anesthesiology |
| 3rd-Party Reviewable | Yes |
| Life-Sustaining | Yes |
Identification
A breathing gas mixer is a device intended for use in conjunction with a respiratory support apparatus to control the mixing of gases that are to be breathed by a patient.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 55)
Showing 20 most recent of 55 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K243917 | F&P Optiflow Air/Oxygen Flow Source | Fisher & Paykel Healthcare, Ltd. | Jul 14, 2025 | SESE |
| K241465 | Midas Flowmeter; eAVS | Parker Hannifin Corporation | Sep 19, 2024 | SESE |
| K231895 | Maxtec MaxBlend2+p | Maxtec, LLC | Dec 4, 2023 | SESE |
| K230987 | FlowStar Analog Mixer Flowmeter | Baldus Sedation GmbH & Co. KG | Sep 14, 2023 | SESE |
| K222794 | FlowStar Touch Digital Mixer Flowmeter | Baldus Sedation GmbH & Co. KG | Jul 28, 2023 | SESE |
| K221494 | Quality Mix Blender, Oxymixer | Dehas Medical Systems GmbH | Jan 23, 2023 | SESE |
| K202480 | Nitronox Plus 0-70, Nitronox 0-50, Nitronox Plus 50/50 | Parker Hannifin | Apr 22, 2021 | SESE |
| K173205 | Equinox Advantage | O-Two Medical Technologies, Inc. | Aug 29, 2018 | SESE |
| K161718 | MaxBlend 2, MaxBlend Lite | Maxtec, LLC | Oct 27, 2016 | SESE |
| K142291 | GMX Series Medical Air/Oxygen Blender | Gentec (Shanghai) Corporation | May 19, 2015 | SESE |
| K113687 | EQUINOX RELIEVE | O-Two Medical Technologies, Inc. | Apr 30, 2012 | SESE |
| K113232 | MAXMIXING BLOCK | Maxtec, Inc. | Mar 1, 2012 | SESE |
| K101286 | SEDARA GAS MIXER, SEDARA SCAVENGER MODEL: 03, 04 | Linde Healthcare AB | Oct 20, 2011 | SESE |
| K103317 | RESUSCITATION UNIT 105 | Atom Medical Corporation | Apr 20, 2011 | SESE |
| K092484 | HELIOX LOW FLOW SENTRY BLENDER | Cardinal Health 207, Inc. | Apr 2, 2010 | SESE |
| K090781 | HELIO2 BLENDER | Precision Medical, Inc. | Aug 13, 2009 | SESE |
| K081335 | TENACORE OXYGEN BLENDER, MODEL TB-2000 | Tenacore Holdings, Inc. | Nov 14, 2008 | SESE |
| K053232 | PRECISION BLENDER | Precision Medical, Inc. | Jan 10, 2006 | SESE |
| K051192 | PRAXAIR MEDICAL AIR MIXER | Praxair, Inc. | Sep 6, 2005 | SESE |
| K050381 | CS MEDICAL TTCF GAS DELIVERY SYSTEM | Cs Medical, Inc. | Jul 13, 2005 | SESE |
Top Applicants
- Bird Products Corp. — 5 clearances
- Sk Med — 4 clearances
- Baldus Sedation GmbH & Co. KG — 2 clearances
- Hamilton Medical, Inc. — 2 clearances
- Maxtec, LLC — 2 clearances
