CAH — Filter, Bacterial, Breathing-Circuit Class II

FDA Device Classification

Classification Details

Product Code
CAH
Device Class
Class II
Regulation Number
868.5260
Submission Type
Review Panel
HO
Medical Specialty
Anesthesiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K241339besmed health businessBesmed Bacterial Filter and HMEFNovember 14, 2024
K222917shaoxing haitech medical products coBreathing circuit bacterial/viral filterFebruary 15, 2024
K230483passy-muirPassy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15)September 16, 2023
K223258intersurgicalTNI Clear-Guard™ 3 angled breathing filter (1545020)June 15, 2023
K221472ningbo huakun medical equipment coFilter and HME/FilterFebruary 8, 2023
K221836drägerwerk ag and co kgaaFilter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar PlusDecember 7, 2022
K221250ndd medizintechnikEasyOne FilterNovember 22, 2022
K210352great group medical coGGM Breathing Circuit Bacterial FilterMarch 27, 2022
K211286pall corporationUltipor U55/U55N Breathing Circuit Filter and Heat and Moisture ExchangerNovember 16, 2021
K202459pharma systemBact-Trap Filter, Bact-Trap Mini, Bact-Trap Midi, Pharma Mini HME/Filter, Bact-HSeptember 26, 2021
K191909flexicare medical limitedHepaShield Bacterial Viral Breathing System FilterMarch 23, 2020
K192713meditera tibbi malzeme san ve ticAltera Filter and HME/FilterMarch 16, 2020
K182862maquet critical careServo GuardOctober 21, 2019
K190022md diagnostics limitedSafeBreath Filter MouthpieceSeptember 25, 2019
K163300flexicare medical limitedThermoShield HME FilterMarch 22, 2017
K151498zhejiang haisheng medical device coBreathing circuit bacterial/viral filterDecember 18, 2015
K141087intersurgical incorporatedINTER-THERM PEDIATRIC HMEF, INTERN-THERM MINI PEDIATRIC ANGLED HMEFFebruary 12, 2015
K132709vr medicalVR MEDICAL HEAT AND MOISTURE EXCHANGER AND FILTERJuly 30, 2014
K132679galemedAF VIRAL/BACTERIAL FILTER, BF VIRAL/BACTERIAL FILTERApril 18, 2014
K131626exceleron medicalEXCELERON BACTERIAL FILTERSFebruary 26, 2014