BSZ · Class II · 21 CFR 868.5160

FDA Product Code BSZ: Gas-machine, Anesthesia

Leading manufacturers include Draeger Medical, Inc., Datex-Ohmeda, Inc. and Ohmeda Medical.

189
Total
189
Cleared
147d
Avg days
1976
Since
Growing category - 3 submissions in the last 2 years vs 2 in the prior period
Review times increasing: avg 202d recently vs 146d historically

FDA 510(k) Cleared Gas-machine, Anesthesia Devices (Product Code BSZ)

189 devices
1–24 of 189
Cleared Jun 25, 2026
A5 Anesthesia System (A5)
K253330
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Anesthesiology · 268d
Cleared May 21, 2026
Atlan (A100)
K252746
Dr?gerwerk AG & Co KGaA
Anesthesiology · 265d
Cleared Jul 11, 2025
Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-700i and related 610i, 620i, 630i series enabled to retrofit RFID features)
K251352
Codonics.Incorporated
Anesthesiology · 72d
Cleared Jul 23, 2023
Atlan
K230931
Dr?gerwerk AG & Co KGaA
Anesthesiology · 111d
Cleared Mar 28, 2023
Carestation 750/750c
K213867
Datex-Ohmeda, Inc.
Anesthesiology · 473d
Cleared Mar 26, 2021
A8, A9 Anesthesia System
K201957
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Anesthesiology · 255d
Cleared Mar 18, 2020
Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System
K191027
Maquet Critical Care AB
Anesthesiology · 335d
Cleared Jan 12, 2018
A7 Anesthesia System
K171292
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Anesthesiology · 255d
Cleared Jan 12, 2018
A5 Anesthesia System
K171311
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Anesthesiology · 255d
Cleared Nov 03, 2017
Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aespire 7100, Aespire 7900, Aespire View, Avance, Avance CS2, Aisys, Aisys CS2
K172045
Datex-Ohmeda, Inc.
Anesthesiology · 120d
Cleared Aug 15, 2017
Aisys CS2
K170872
Datex-Ohmeda, Inc.
Anesthesiology · 145d
Cleared Jan 21, 2016
Carestation 620/650/650C
K151570
Datex-Ohmeda, Inc.
Anesthesiology · 225d
Cleared Oct 27, 2015
A7 Anesthesia System
K151954
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Anesthesiology · 104d
Cleared Apr 24, 2015
Aespire View
K143530
Datex-Ohmeda, Inc.
Anesthesiology · 133d
Cleared Jan 23, 2015
A7 Anesthesia System
K142552
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Anesthesiology · 135d
Cleared Dec 20, 2013
GE DATEX-OHMEDA AISYS CS2 (AISYS CS^2)
K132530
Datex-Ohmeda, Inc.
Anesthesiology · 130d
Cleared Aug 08, 2013
GE DATEX-OHMEDA AVANCE CS2
K131945
Datex-Ohmeda
Anesthesiology · 42d
Cleared Feb 06, 2013
GE DATEX-OHMEDA AVANCE CS2
K123125
Datex-Ohmeda, Inc.
Anesthesiology · 125d
Cleared Oct 12, 2012
AESPIRE 7900, AESPIRE VIEW
K122445
Datex-Ohmeda
Anesthesiology · 63d
Cleared Dec 16, 2011
GE DATEX-OHMEDA AVANCE
K112722
Datex-Ohmeda, Inc.
Anesthesiology · 88d
Cleared Jul 20, 2011
GE DATEX-OHMEDA AISYS
K110213
Datex-Ohmeda, Inc.
Anesthesiology · 176d
Cleared Mar 05, 2009
GE DATEX-OHMEDA AISYS
K090233
Datex-Ohmeda, Inc.
Anesthesiology · 34d
Cleared Dec 18, 2008
COMPURECORD PERI-OPERATIVE ANESTHESIOLOGY INFORMATION SYSTEM
K083413
Philips Medical Systems
Anesthesiology · 30d
Cleared Aug 29, 2008
GE DATEX-OHMEDA AVANCE
K081844
Datex-Ohmeda, Inc.
Anesthesiology · 60d

About Product Code BSZ - Regulatory Context

510(k) Submission Activity

189 total 510(k) submissions under product code BSZ since 1976, with 189 receiving FDA clearance (average review time: 147 days).

Submission volume has increased in recent years - 3 submissions in the last 24 months compared to 2 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - BSZ Product Code

Recent submissions under BSZ have taken an average of 202 days to reach a decision - up from 146 days historically. Manufacturers should account for longer review timelines in current project planning.

BSZ devices are reviewed by the Anesthesiology panel. Browse all Anesthesiology devices →