Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart F — Therapeutic Devices](/submissions/AN/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 868.5160](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5160) → BSZ — Gas-Machine, Anesthesia # BSZ · Gas-Machine, Anesthesia _Anesthesiology · 21 CFR 868.5160 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSZ ## Overview - **Product Code:** BSZ - **Device Name:** Gas-Machine, Anesthesia - **Regulation:** [21 CFR 868.5160](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5160) - **Device Class:** 2 - **Review Panel:** [Anesthesiology](/submissions/AN) - **Life-sustaining:** yes ## Identification A gas machine for anesthesia is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. The device may include a gas flowmeter, vaporizer, ventilator, breathing circuit with bag, and emergency air supply. A gas machine for analgesia is a device used to administer to a patient an analgesic agent, such as a nitrous oxide-oxygen mixture (maximum concentration of 70 percent nitrous oxide). ## Classification Rationale Class II (performance standards). ## Recent Cleared Devices (20 of 187) Showing 20 most recent of 187 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K251352](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSZ/K251352.md) | Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-700i and related 610i, 620i, 630i series enabled to retrofit RFID features); Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-1, SLS XXX, Multiple Models Pending Configuration) | Codonics.Incorporated | Jul 11, 2025 | SESE | | [K230931](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSZ/K230931.md) | Atlan | Drägerwerk AG Co. Kgaa | Jul 23, 2023 | SESE | | [K213867](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSZ/K213867.md) | Carestation 750/750c | Datex-Ohmeda, Inc. | Mar 28, 2023 | SESE | | [K201957](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSZ/K201957.md) | A8, A9 Anesthesia System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | Mar 26, 2021 | SESE | | [K191027](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSZ/K191027.md) | Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System | Maquet Critical Care AB | Mar 18, 2020 | SESE | | [K171311](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSZ/K171311.md) | A5 Anesthesia System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | Jan 12, 2018 | SESE | | [K171292](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSZ/K171292.md) | A7 Anesthesia System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | Jan 12, 2018 | SESE | | [K172045](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSZ/K172045.md) | Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aespire 7100, Aespire 7900, Aespire View, Avance, Avance CS2, Aisys, Aisys CS2 | Datex-Ohmeda, Inc. | Nov 3, 2017 | SESE | | [K170872](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSZ/K170872.md) | Aisys CS2 | Datex-Ohmeda, Inc. | Aug 15, 2017 | SESE | | [K160665](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSZ/K160665.md) | FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia System C40 | Maquet Critical Care AB | Mar 29, 2017 | SESE | | [K151570](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSZ/K151570.md) | Carestation 620/650/650C | Datex-Ohmeda, Inc. | Jan 21, 2016 | SESE | | [K151954](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSZ/K151954.md) | A7 Anesthesia System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | Oct 27, 2015 | SESE | | [K143530](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSZ/K143530.md) | Aespire View | Datex-Ohmeda, Inc. | Apr 24, 2015 | SESE | | [K142552](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSZ/K142552.md) | A7 Anesthesia System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | Jan 23, 2015 | SESE | | [K140264](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSZ/K140264.md) | MADM | Thornhill Research, Inc. | Jan 5, 2015 | SESE | | [K132903](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSZ/K132903.md) | DRE VENTURA | Dre Medical, Inc. | Jul 1, 2014 | SESE | | [K133886](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSZ/K133886.md) | PERSEUS A500 | Draeger Medical GmbH | Jun 20, 2014 | SESE | | [K131790](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSZ/K131790.md) | A9800 ANESTHESIA WORKSTATION | Oricare, Inc. | May 9, 2014 | SESE | | [K133958](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSZ/K133958.md) | FLOW-I ANESTHESIA SYSTEM C20, C30 & C40 | Maquet Critical Care AB | Mar 20, 2014 | SESE | | [K132530](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSZ/K132530.md) | GE DATEX-OHMEDA AISYS CS2 (AISYS CS^2) | Datex-Ohmeda, Inc. | Dec 20, 2013 | SESE | ## Top Applicants - Draeger Medical, Inc. — 33 clearances - Datex-Ohmeda, Inc. — 20 clearances - Ohmeda Medical — 17 clearances - GE Healthcare Finland Oy — 5 clearances - Maquet Critical Care AB — 5 clearances --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSZ](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSZ) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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