BSZ · Class II · 21 CFR 868.5160

FDA Product Code BSZ: Gas-machine, Anesthesia

Leading manufacturers include Shenzhen Mindray Bio-Medical Electronics Co., Ltd., Dr?gerwerk AG & Co KGaA and Codonics.Incorporated.

188
Total
188
Cleared
146d
Avg days
1976
Since
Stable submission activity - 2 submissions in the last 2 years
Review times increasing: avg 169d recently vs 146d historically

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

188 devices
1–24 of 188
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 Sep 13, 1999
KION ANESTHESIA SYSTEM
K973971
Siemens Medical Solutions USA, Inc.
Anesthesiology · 696d
Cleared Aug 01, 1989
CAVENDISH 460/680 ANESTHESIA MACHINE
K884802
Dentsply Intl.
Anesthesiology · 257d

About Product Code BSZ - Regulatory Context

510(k) Submission Activity

188 total 510(k) submissions under product code BSZ since 1976, with 188 receiving FDA clearance (average review time: 146 days).

Submission volume has remained relatively stable over the observed period, with 2 submissions in the last 24 months.

FDA 510(k) Review Time - BSZ Product Code

Recent submissions under BSZ have taken an average of 169 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 →