ClearanceBrief
Panels › Anesthesiology › Product code CAH · Class 2

Filter, Bacterial, Breathing-Circuit

Regulation 868.5260

2510(k)s in 12 months (202 all time)
1recalls in 12 months (28 all time)
27recalls that name a 510(k)
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Top companies in CAH

Decided510(k)Device and applicantCode
May 15, 2026K252643Iso-Gard Filter Straight; Humid-Vent Filter Compact Angled
Teleflex Medical Sdn. Bhd., MY
CAH
Apr 30, 2026K251583Ambu® Virobac II® Exhalation Filter
Ambu A/S, DK
CAH
Nov 14, 2024K241339Besmed Bacterial Filter and HMEF
Besmed Health Business Corp, TW
CAH
Feb 15, 2024K222917Breathing circuit bacterial/viral filter
Shaoxing Haitech Medical Products Co., Ltd., CN
CAH
Sep 16, 2023K230483Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15)
Passy-Muir, Inc.
CAH
Jun 15, 2023K223258TNI Clear-Guard™ 3 angled breathing filter (1545020)
Intersurgical , Ltd., GB
CAH
Feb 8, 2023K221472Filter and HME/Filter
Ningbo Huakun Medical Equipment Co., Ltd., CN
CAH
Dec 7, 2022K221836Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus
Drägerwerk AG & Co. KGaA, DE
CAH
Nov 22, 2022K221250EasyOne Filter
Ndd Medizintechnik AG, CH
CAH
Mar 27, 2022K210352GGM Breathing Circuit Bacterial Filter
Great Group Medical Co, Ltd., TW
CAH
Nov 16, 2021K211286Ultipor U55/U55N Breathing Circuit Filter and Heat and Moisture Exchanger
Pall Corporation
CAH
Sep 26, 2021K202459Bact-Trap Filter, Bact-Trap Mini, Bact-Trap Midi, Pharma Mini HME/Filter, Bact-HME HME/Filter and Bact-HME Midi HME/Filt
Pharma System AB, SE
CAH
Mar 23, 2020K191909HepaShield Bacterial Viral Breathing System Filter
Flexicare Medical Limited., GB
CAH
Mar 16, 2020K192713Altera Filter and HME/Filter
Meditera Tibbi Malzeme San VE Tic AS, TR
CAH
Oct 21, 2019K182862Servo Guard
Maquet Critical Care AB, SE
CAH
Sep 25, 2019K190022SafeBreath Filter Mouthpiece
MD Diagnostics Limited, GB
CAH
Mar 22, 2017K163300ThermoShield HME Filter
Flexicare Medical Limited., GB
CAH
Dec 18, 2015K151498Breathing circuit bacterial/viral filter
Zhejiang Haisheng Medical Device Co., Ltd., CN
CAH
Feb 12, 2015K141087INTER-THERM PEDIATRIC HMEF, INTERN-THERM MINI PEDIATRIC ANGLED HMEF
Intersurgical Incorporated
CAH
Jul 30, 2014K132709VR MEDICAL HEAT AND MOISTURE EXCHANGER AND FILTER
Vr Medical, CN
CAH
Apr 18, 2014K132679AF VIRAL/BACTERIAL FILTER, BF VIRAL/BACTERIAL FILTER
Galemed Corp.
CAH
Feb 26, 2014K131626EXCELERON BACTERIAL FILTERS
Exceleron Medical
CAH
Feb 5, 2014K133666RT016 INSPIRATORY FILTER
Fisher & Paykel Healthcare, Ltd., NZ
CAH
Jun 21, 2013K130664HYRDROMAX HMEF
A-M Systems
CAH
Dec 6, 2012K121382WESTMED, INC.'S BLOCKAIDE FILTER [21 CFR 807.87(A)]
Westmed, Inc.
CAH
Nov 2, 2012K121026FLO-GUARD BREATHING FILTER
Intersurgical, Inc.
CAH
Sep 21, 2012K112958HUMID-VENT HEPA
Teleflex Medical
CAH
Nov 4, 2011K110246MEDISIZE RED AND MEDISIZE BLUE
Qserve America, Inc.
CAH
Oct 17, 2011K111408MICROGARD II
Carefusion Germany 234 GmbH, DE
CAH
Sep 13, 2011K102483SUNSET HEALTHCARE SOLUTIONS BACTERIAL/VIRAL HME FILTER, MODEL BHF 104
Sunset Healthcare Solutions, LLC
CAH
Oct 29, 2010K092451INTERSURGICAL INTER-THERM BREATHING FILTER AND HEAT AND MOISTURE EXCHANGER, INTERSURGICAL INTER-GUARD BREATHING FILTER
Intersurgical, Inc.
CAH
Jul 9, 2010K101629FIL 1520
Glenn Medical Systems, Inc.
CAH
Mar 10, 2010K092409HYDRO-GUARD MINI BREATHING FILTER AND HEAT AND MOISTURE EXCHANGER AND AIR-GUARD CLEAR BREATHING FILTER
Intersurgical, Inc.
CAH
Feb 22, 2010K093426BACT-TRAP HEPA MIDI
Pharma Systems AB
CAH
Feb 4, 2010K091363COMPRESSOR FILTER, MODELS AG1038831, HCF100,BF900,BF910,BF950, LL201, LL202, LL205, BACTERIA FILTER
Ag Industries
CAH
Oct 6, 2009K092218FLEXICARE BREATHING FILTERS
Flexicare Medical, Ltd., GB
CAH
Jul 27, 2009K090738THERMOFLO HCH, THERMOFLO FILTER
Arc Medical, Inc.
CAH
Jul 24, 2009K09118570530-BACTIAL/VIRAL FILTER, 70531-HMEF, 70536-BACTERIAL/VIRAL FILTER
Hsiner Co., Ltd.
CAH
Jan 23, 2009K081536MEDISIZE BLUE, MEDISIZE GREEN, MEDISIZE RED
Medisize BV, NL
CAH
Jan 31, 2008K072002FILTER CARESTAR 30; FILTER SAFESTAR 55; FILTER/HME TWINSTAR 55
Draeger Medical AG & Co. KG
CAH
Jun 29, 2007K063526A-M SYSTEMS VIROMAX VIRAL AND BACTERIAL FILTER
A-M Systems, Inc.
CAH
Apr 13, 2007K063125FILTERFLO HEPA; THERMOFLO HEPA (FILTER / HME)
Arc Medical, Inc.
CAH
Jun 5, 2006K061426OXYGEN CONCENTRATOR FILTERS, MODELS DBF32, DBF24, DBF27, DBF25, DFC06 AND DDF47
Porous Media Corp.
CAH
Dec 14, 2005K052087BREATHING FILTER BACTERIAL/VIRAL, MODEL AG7178
Ag Industries
CAH
Aug 1, 2005K050927RT019 INSPIRATORY/EXPIRATORY FILTER
Fisher & Paykel Healthcare, Ltd., NZ
CAH
Jun 29, 2005K050953AIR SAFETY MODEL 3000/06 FILTER HEPA REUSABLE
Air Safety, Ltd.
CAH
Mar 1, 2005K043120MIN-FILTER/S, UNI-FILTER JUNIOR, UNI-FILTER/S ANGLED AND UNI-FILTER
Datex-Ohmeda, Inc.
CAH
Dec 13, 2004K043148ALL FLOW PULMONARY FUNCTION FILTER
Alliance Tech Medical, Inc.
CAH
Sep 20, 2004K032878KUNG SHIN, HMEF SK203
Kung Shin Plastics Co., Ltd., TW
CAH
May 13, 2004K033008AIR SAFETY HEPA AND NON-HEPA FILTERS
Air Safety, Ltd.
CAH

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