BZR — Mixer, Breathing Gases, Anesthesia Inhalation Class II

FDA Device Classification

Classification Details

Product Code
BZR
Device Class
Class II
Regulation Number
868.5330
Submission Type
Review Panel
AN
Medical Specialty
Anesthesiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K243917fisher and paykel healthcareF&P Optiflow Air/Oxygen Flow SourceJuly 14, 2025
K241465parker hannifin corporationMidas Flowmeter; eAVSSeptember 19, 2024
K231895maxtecMaxtec MaxBlend2+pDecember 4, 2023
K230987baldus sedation gmbh and co. kgFlowStar Analog Mixer FlowmeterSeptember 14, 2023
K222794baldus sedation gmbh and co. kgFlowStar Touch Digital Mixer FlowmeterJuly 28, 2023
K221494dehas medical systemsQuality Mix Blender, OxymixerJanuary 23, 2023
K202480parker hannifinNitronox Plus 0-70, Nitronox 0-50, Nitronox Plus 50/50April 22, 2021
K173205o-two medical technologiesEquinox AdvantageAugust 29, 2018
K161718maxtecMaxBlend 2, MaxBlend LiteOctober 27, 2016
K142291gentec (shanghai) corporationGMX Series Medical Air/Oxygen BlenderMay 19, 2015
K113687o-two medical technologiesEQUINOX RELIEVEApril 30, 2012
K113232maxtecMAXMIXING BLOCKMarch 1, 2012
K101286linde healthcareSEDARA GAS MIXER, SEDARA SCAVENGER MODEL: 03, 04October 20, 2011
K103317atom medical corporationRESUSCITATION UNIT 105April 20, 2011
K092484cardinal health 207HELIOX LOW FLOW SENTRY BLENDERApril 2, 2010
K090781precision medicalHELIO2 BLENDERAugust 13, 2009
K081335tenacore holdingsTENACORE OXYGEN BLENDER, MODEL TB-2000November 14, 2008
K053232precision medicalPRECISION BLENDERJanuary 10, 2006
K051192praxairPRAXAIR MEDICAL AIR MIXERSeptember 6, 2005
K050381cs medicalCS MEDICAL TTCF GAS DELIVERY SYSTEMJuly 13, 2005