BZR · Class II · 21 CFR 868.5330

FDA Product Code BZR: Mixer, Breathing Gases, Anesthesia Inhalation

Leading manufacturers include Baldus Sedation GmbH & Co. KG, O-Two Medical Technologies, Inc. and Parker Hannifin.

55
Total
55
Cleared
142d
Avg days
1976
Since
Declining activity - 2 submissions in the last 2 years vs 4 in the prior period
Consistent review times: 163d avg (recent)

FDA 510(k) Cleared Mixer, Breathing Gases, Anesthesia Inhalation Devices (Product Code BZR)

55 devices
1–24 of 55
Cleared Jul 14, 2025
F&P Optiflow Air/Oxygen Flow Source
K243917
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 206d
Cleared Sep 19, 2024
Midas Flowmeter
K241465
Parker Hannifin Corporation
Anesthesiology · 119d
Cleared Dec 04, 2023
Maxtec MaxBlend2+p
K231895
Maxtec, LLC
Anesthesiology · 159d
Cleared Sep 14, 2023
FlowStar Analog Mixer Flowmeter
K230987
Baldus Sedation GmbH & Co. KG
Anesthesiology · 161d
Cleared Jul 28, 2023
FlowStar Touch Digital Mixer Flowmeter
K222794
Baldus Sedation GmbH & Co. KG
Anesthesiology · 315d
Cleared Jan 23, 2023
Quality Mix Blender, Oxymixer
K221494
Dehas Medical Systems GmbH
Anesthesiology · 245d
Cleared Apr 22, 2021
Nitronox Plus 0-70, Nitronox 0-50, Nitronox Plus 50/50
K202480
Parker Hannifin
Anesthesiology · 237d
Cleared Aug 29, 2018
Equinox Advantage
K173205
O-Two Medical Technologies, Inc.
Anesthesiology · 331d

About Product Code BZR - Regulatory Context

510(k) Submission Activity

55 total 510(k) submissions under product code BZR since 1976, with 55 receiving FDA clearance (average review time: 142 days).

Submission volume has declined in recent years - 2 submissions in the last 24 months compared to 4 in the prior period.

FDA 510(k) Review Time - BZR Product Code

FDA review times for BZR submissions have been consistent, averaging 163 days recently vs 142 days historically.

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