Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart F — Therapeutic Devices](/submissions/AN/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 868.5330](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5330) → BZR — Mixer, Breathing Gases, Anesthesia Inhalation # BZR · Mixer, Breathing Gases, Anesthesia Inhalation _Anesthesiology · 21 CFR 868.5330 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZR ## Overview - **Product Code:** BZR - **Device Name:** Mixer, Breathing Gases, Anesthesia Inhalation - **Regulation:** [21 CFR 868.5330](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5330) - **Device Class:** 2 - **Review Panel:** [Anesthesiology](/submissions/AN) - **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](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZR/K243917.md) | F&P Optiflow Air/Oxygen Flow Source | Fisher & Paykel Healthcare, Ltd. | Jul 14, 2025 | SESE | | [K241465](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZR/K241465.md) | Midas Flowmeter; eAVS | Parker Hannifin Corporation | Sep 19, 2024 | SESE | | [K231895](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZR/K231895.md) | Maxtec MaxBlend2+p | Maxtec, LLC | Dec 4, 2023 | SESE | | [K230987](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZR/K230987.md) | FlowStar Analog Mixer Flowmeter | Baldus Sedation GmbH & Co. KG | Sep 14, 2023 | SESE | | [K222794](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZR/K222794.md) | FlowStar Touch Digital Mixer Flowmeter | Baldus Sedation GmbH & Co. KG | Jul 28, 2023 | SESE | | [K221494](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZR/K221494.md) | Quality Mix Blender, Oxymixer | Dehas Medical Systems GmbH | Jan 23, 2023 | SESE | | [K202480](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZR/K202480.md) | Nitronox Plus 0-70, Nitronox 0-50, Nitronox Plus 50/50 | Parker Hannifin | Apr 22, 2021 | SESE | | [K173205](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZR/K173205.md) | Equinox Advantage | O-Two Medical Technologies, Inc. | Aug 29, 2018 | SESE | | [K161718](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZR/K161718.md) | MaxBlend 2, MaxBlend Lite | Maxtec, LLC | Oct 27, 2016 | SESE | | [K142291](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZR/K142291.md) | GMX Series Medical Air/Oxygen Blender | Gentec (Shanghai) Corporation | May 19, 2015 | SESE | | [K113687](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZR/K113687.md) | EQUINOX RELIEVE | O-Two Medical Technologies, Inc. | Apr 30, 2012 | SESE | | [K113232](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZR/K113232.md) | MAXMIXING BLOCK | Maxtec, Inc. | Mar 1, 2012 | SESE | | [K101286](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZR/K101286.md) | SEDARA GAS MIXER, SEDARA SCAVENGER MODEL: 03, 04 | Linde Healthcare AB | Oct 20, 2011 | SESE | | [K103317](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZR/K103317.md) | RESUSCITATION UNIT 105 | Atom Medical Corporation | Apr 20, 2011 | SESE | | [K092484](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZR/K092484.md) | HELIOX LOW FLOW SENTRY BLENDER | Cardinal Health 207, Inc. | Apr 2, 2010 | SESE | | [K090781](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZR/K090781.md) | HELIO2 BLENDER | Precision Medical, Inc. | Aug 13, 2009 | SESE | | [K081335](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZR/K081335.md) | TENACORE OXYGEN BLENDER, MODEL TB-2000 | Tenacore Holdings, Inc. | Nov 14, 2008 | SESE | | [K053232](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZR/K053232.md) | PRECISION BLENDER | Precision Medical, Inc. | Jan 10, 2006 | SESE | | [K051192](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZR/K051192.md) | PRAXAIR MEDICAL AIR MIXER | Praxair, Inc. | Sep 6, 2005 | SESE | | [K050381](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZR/K050381.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZR](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZR) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com