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/productcode/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 188)

Showing 20 most recent of 188 cleared devices.

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K252746](/device/K252746.md) | Atlan (A100); Atlan (A100 XL); Atlan(A350); Atlan (A350 XL) | Drägerwerk AG Co. Kgaa | May 21, 2026 | SESE |
| [K251352](/device/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](/device/K230931.md) | Atlan | Drägerwerk AG Co. Kgaa | Jul 23, 2023 | SESE |
| [K213867](/device/K213867.md) | Carestation 750/750c | Datex-Ohmeda, Inc. | Mar 28, 2023 | SESE |
| [K201957](/device/K201957.md) | A8, A9 Anesthesia System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | Mar 26, 2021 | SESE |
| [K191027](/device/K191027.md) | Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System | Maquet Critical Care AB | Mar 18, 2020 | SESE |
| [K171311](/device/K171311.md) | A5 Anesthesia System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | Jan 12, 2018 | SESE |
| [K171292](/device/K171292.md) | A7 Anesthesia System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | Jan 12, 2018 | SESE |
| [K172045](/device/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](/device/K170872.md) | Aisys CS2 | Datex-Ohmeda, Inc. | Aug 15, 2017 | SESE |
| [K160665](/device/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](/device/K151570.md) | Carestation 620/650/650C | Datex-Ohmeda, Inc. | Jan 21, 2016 | SESE |
| [K151954](/device/K151954.md) | A7 Anesthesia System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | Oct 27, 2015 | SESE |
| [K143530](/device/K143530.md) | Aespire View | Datex-Ohmeda, Inc. | Apr 24, 2015 | SESE |
| [K142552](/device/K142552.md) | A7 Anesthesia System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | Jan 23, 2015 | SESE |
| [K140264](/device/K140264.md) | MADM | Thornhill Research, Inc. | Jan 5, 2015 | SESE |
| [K132903](/device/K132903.md) | DRE VENTURA | Dre Medical, Inc. | Jul 1, 2014 | SESE |
| [K133886](/device/K133886.md) | PERSEUS A500 | Draeger Medical GmbH | Jun 20, 2014 | SESE |
| [K131790](/device/K131790.md) | A9800 ANESTHESIA WORKSTATION | Oricare, Inc. | May 9, 2014 | SESE |
| [K133958](/device/K133958.md) | FLOW-I ANESTHESIA SYSTEM C20, C30 & C40 | Maquet Critical Care AB | Mar 20, 2014 | 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

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**Source:** [https://fda.innolitics.com/productcode/BSZ](https://fda.innolitics.com/productcode/BSZ)

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