BSZ · Gas-Machine, Anesthesia
Anesthesiology · 21 CFR 868.5160 · Class 2
Overview
| Product Code | BSZ |
|---|---|
| Device Name | Gas-Machine, Anesthesia |
| Regulation | 21 CFR 868.5160 |
| Device Class | Class 2 |
| Review Panel | Anesthesiology |
| 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 | 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 | Atlan | Drägerwerk AG Co. Kgaa | Jul 23, 2023 | SESE |
| K213867 | Carestation 750/750c | Datex-Ohmeda, Inc. | Mar 28, 2023 | SESE |
| K201957 | A8, A9 Anesthesia System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | Mar 26, 2021 | SESE |
| K191027 | Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System | Maquet Critical Care AB | Mar 18, 2020 | SESE |
| K171311 | A5 Anesthesia System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | Jan 12, 2018 | SESE |
| K171292 | A7 Anesthesia System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | Jan 12, 2018 | SESE |
| K172045 | 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 | Aisys CS2 | Datex-Ohmeda, Inc. | Aug 15, 2017 | SESE |
| K160665 | FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia System C40 | Maquet Critical Care AB | Mar 29, 2017 | SESE |
| K151570 | Carestation 620/650/650C | Datex-Ohmeda, Inc. | Jan 21, 2016 | SESE |
| K151954 | A7 Anesthesia System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | Oct 27, 2015 | SESE |
| K143530 | Aespire View | Datex-Ohmeda, Inc. | Apr 24, 2015 | SESE |
| K142552 | A7 Anesthesia System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | Jan 23, 2015 | SESE |
| K140264 | MADM | Thornhill Research, Inc. | Jan 5, 2015 | SESE |
| K132903 | DRE VENTURA | Dre Medical, Inc. | Jul 1, 2014 | SESE |
| K133886 | PERSEUS A500 | Draeger Medical GmbH | Jun 20, 2014 | SESE |
| K131790 | A9800 ANESTHESIA WORKSTATION | Oricare, Inc. | May 9, 2014 | SESE |
| K133958 | FLOW-I ANESTHESIA SYSTEM C20, C30 & C40 | Maquet Critical Care AB | Mar 20, 2014 | SESE |
| K132530 | 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
