Filter, Bacterial, Breathing-Circuit

FDA product code CAH · 196 cleared devices

Class 2 Anesthesiology

Regulation: 21 CFR 868.5260
Review panel: HO
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1976-07-15 – 2026-05-15

CAH 2026-05-15

Iso-Gard Filter Straight; Humid-Vent Filter Compact Angled

Applicant Teleflex Medical Sdn. Bhd.

K number K252643

View details →

CAH 2026-04-30

Ambu® Virobac II® Exhalation Filter

Applicant Ambu A/S

K number K251583

View details →

CAH 2024-11-14

Besmed Bacterial Filter and HMEF

Applicant Besmed Health Business Corp

K number K241339

View details →

CAH 2024-02-15

Breathing circuit bacterial/viral filter

Applicant Shaoxing Haitech Medical Products Co., Ltd.

K number K222917

View details →

CAH 2023-09-16

Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15)

Applicant Passy-Muir, Inc.

K number K230483

View details →

CAH 2023-06-15

TNI Clear-Guard™ 3 angled breathing filter (1545020)

Applicant Intersurgical , Ltd.

K number K223258

View details →

CAH 2023-02-08

Filter and HME/Filter

Applicant Ningbo Huakun Medical Equipment Co., Ltd.

K number K221472

View details →

CAH 2022-12-07

Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus

Applicant Drägerwerk AG & Co. KGaA

K number K221836

View details →

CAH 2022-11-22

EasyOne Filter

Applicant Ndd Medizintechnik AG

K number K221250

View details →

CAH 2022-03-27

GGM Breathing Circuit Bacterial Filter

Applicant Great Group Medical Co, Ltd.

K number K210352

View details →

CAH 2021-11-16

Ultipor U55/U55N Breathing Circuit Filter and Heat and Moisture Exchanger

Applicant Pall Corporation

K number K211286

View details →

CAH 2021-09-26

Bact-Trap Filter, Bact-Trap Mini, Bact-Trap Midi, Pharma Mini HME/Filter, Bact-HME HME/Filter and Bact-HME Midi HME/Filter

Applicant Pharma System AB

K number K202459

View details →

CAH 2020-03-23

HepaShield Bacterial Viral Breathing System Filter

Applicant Flexicare Medical Limited.

K number K191909

View details →

CAH 2020-03-16

Altera Filter and HME/Filter

Applicant Meditera Tibbi Malzeme San VE Tic AS

K number K192713

View details →

CAH 2019-10-21

Servo Guard

Applicant Maquet Critical Care AB

K number K182862

View details →

CAH 2019-09-25

SafeBreath Filter Mouthpiece

Applicant MD Diagnostics Limited

K number K190022

View details →

CAH 2017-03-22

ThermoShield HME Filter

Applicant Flexicare Medical Limited.

K number K163300

View details →

CAH 2013-06-21

HYRDROMAX HMEF

Applicant A-M Systems

K number K130664

View details →

CAH 2012-12-06

WESTMED, INC.'S BLOCKAIDE FILTER [21 CFR 807.87(A)]

Applicant Westmed, Inc.

K number K121382

View details →

CAH 2012-11-02

FLO-GUARD BREATHING FILTER

Applicant Intersurgical, Inc.

K number K121026

View details →

CAH 2012-09-21

HUMID-VENT HEPA

Applicant Teleflex Medical

K number K112958

View details →

CAH 2011-11-04

MEDISIZE RED AND MEDISIZE BLUE

Applicant Qserve America, Inc.

K number K110246

View details →

CAH 2011-10-17

MICROGARD II

Applicant Carefusion Germany 234 GmbH

K number K111408

View details →

CAH 2011-09-13

SUNSET HEALTHCARE SOLUTIONS BACTERIAL/VIRAL HME FILTER, MODEL BHF 104

Applicant Sunset Healthcare Solutions, LLC

K number K102483

View details →

CAH 2010-10-29

INTERSURGICAL INTER-THERM BREATHING FILTER AND HEAT AND MOISTURE EXCHANGER, INTERSURGICAL INTER-GUARD BREATHING FILTER

Applicant Intersurgical, Inc.

K number K092451

View details →

CAH 2010-07-09

FIL 1520

Applicant Glenn Medical Systems, Inc.

K number K101629

View details →

CAH 2010-03-10

HYDRO-GUARD MINI BREATHING FILTER AND HEAT AND MOISTURE EXCHANGER AND AIR-GUARD CLEAR BREATHING FILTER

Applicant Intersurgical, Inc.

K number K092409

View details →

CAH 2010-02-22

BACT-TRAP HEPA MIDI

Applicant Pharma Systems AB

K number K093426

View details →

CAH 2010-02-04

COMPRESSOR FILTER, MODELS AG1038831, HCF100,BF900,BF910,BF950, LL201, LL202, LL205, BACTERIA FILTER

Applicant Ag Industries

K number K091363

View details →

CAH 2009-10-06

FLEXICARE BREATHING FILTERS

Applicant Flexicare Medical, Ltd.

K number K092218

View details →

CAH 2009-07-27

THERMOFLO HCH, THERMOFLO FILTER

Applicant Arc Medical, Inc.

K number K090738

View details →

CAH 2009-07-24

70530-BACTIAL/VIRAL FILTER, 70531-HMEF, 70536-BACTERIAL/VIRAL FILTER

Applicant Hsiner Co., Ltd.

K number K091185

View details →

CAH 2009-01-23

MEDISIZE BLUE, MEDISIZE GREEN, MEDISIZE RED

Applicant Medisize BV

K number K081536

View details →

CAH 2008-01-31

FILTER CARESTAR 30; FILTER SAFESTAR 55; FILTER/HME TWINSTAR 55

Applicant Draeger Medical AG & Co. KG

K number K072002

View details →

CAH 2007-06-29

A-M SYSTEMS VIROMAX VIRAL AND BACTERIAL FILTER

Applicant A-M Systems, Inc.

K number K063526

View details →

CAH 2007-04-13

FILTERFLO HEPA; THERMOFLO HEPA (FILTER / HME)

Applicant Arc Medical, Inc.

K number K063125

View details →

CAH 2006-06-05

OXYGEN CONCENTRATOR FILTERS, MODELS DBF32, DBF24, DBF27, DBF25, DFC06 AND DDF47

Applicant Porous Media Corp.

K number K061426

View details →

CAH 2005-12-14

BREATHING FILTER BACTERIAL/VIRAL, MODEL AG7178

Applicant Ag Industries

K number K052087

View details →

CAH 2005-08-01

RT019 INSPIRATORY/EXPIRATORY FILTER

Applicant Fisher & Paykel Healthcare, Ltd.

K number K050927

View details →

CAH 2005-06-29

AIR SAFETY MODEL 3000/06 FILTER HEPA REUSABLE

Applicant Air Safety, Ltd.

K number K050953

View details →

CAH 2005-03-01

MIN-FILTER/S, UNI-FILTER JUNIOR, UNI-FILTER/S ANGLED AND UNI-FILTER

Applicant Datex-Ohmeda, Inc.

K number K043120

View details →

CAH 2004-12-13

ALL FLOW PULMONARY FUNCTION FILTER

Applicant Alliance Tech Medical, Inc.

K number K043148

View details →

CAH 2004-09-20

KUNG SHIN, HMEF SK203

Applicant Kung Shin Plastics Co., Ltd.

K number K032878

View details →

CAH 2004-05-13

AIR SAFETY HEPA AND NON-HEPA FILTERS

Applicant Air Safety, Ltd.

K number K033008

View details →

CAH 2004-05-13

CLEAR-THERM MICRO HME, MODEL 1441

Applicant Intersurgical, Inc.

K number K032322

View details →

CAH 2004-04-26

SERVO GUARD, MODEL 64 81 290 EH88E

Applicant Maquet, Inc.

K number K030071

View details →

CAH 2003-11-28

PORTEX THERMOVENT HEPA HME BREATHING FILTER WITH CO2 PORT (STERILE AND NON-STERILE)

Applicant Portex , Ltd.

K number K032716

View details →

CAH 2003-07-07

VENTLAB BACTERIAL FILTER, MODEL BF100

Applicant Ventlab Corp.

K number K030271

View details →

CAH 2003-06-25

DATEX-OHMEDA MINI-FILTER/S AND UNI-FILTER JUNIOR

Applicant Datex-Ohmeda

K number K030990

View details →

CAH 2003-06-24

CLEAR-THERM 3 HMEF, CLEAR-THERM 3 WITH SUPERSET CATHETER MOUNT,CLEAR-THERM WITH FLEXIBLE CATHETER MOUNT,CLEAR-GUARD 3 F3

Applicant Intersurgical, Inc.

K number K024270

View details →

CAH 2003-06-20

DATEX-OHMEDA HMEF 750

Applicant Datex-Ohmeda

K number K031653

View details →

CAH 2002-11-27

DATEX-OHMEDA HMEF MINI

Applicant Datex-Ohmeda

K number K023641

View details →

CAH 2002-08-30

DATEX-OHMEDA HMEF 500

Applicant Datex-Ohmeda

K number K021265

View details →

CAH 2002-08-01

PALL ULTIPOR ANESTHESIA BREATHING SYSTEM

Applicant Pall Medical

K number K013093

View details →

CAH 2002-06-26

BACSTOP FILTER,BACSTOP FILTER/HME

Applicant Munktell Filter AB

K number K014282

View details →

CAH 2002-06-26

GARD FILTER, COMBIGARD FILTE / HME

Applicant Munktell Filter AB

K number K014281

View details →

CAH 2002-06-10

TERUMO GAS FILTER

Applicant Terumo Cardiovascular Systems Corp.

K number K021020

View details →

CAH 2002-04-19

EMS ELECTROSTATIC FLITER AND HME COMBINATION

Applicant Engineered Medical Systems

K number K013122

View details →

CAH 2002-03-14

EMS HEPA FILTER AND HME COMBINATIONS

Applicant Engineered Medical Systems

K number K013089

View details →

CAH 2002-02-22

BREATHING CIRCUIT FILTER

Applicant Emergency Filtration Products, Inc.

K number K012958

View details →

CAH 2001-12-20

FILTERFLO H

Applicant Arc Medical, Inc.

K number K011212

View details →

CAH 2001-12-14

RENMED CONTAMI-SHIELD BREATHING CIRCUIT SLEEVE, MODEL 9999/01

Applicant Rennels Medical Corp.

K number K013200

View details →

CAH 2001-10-09

MS-140 ALL-ROUND ENHANCED PERFORMANCE FILTER; MS-141 ALL-ROUND ENHANCED PERFORMANCE ANGLED; MS-142 ALL-ROUND/HME ENHANCE

Applicant King Systems Corp.

K number K012485

View details →

CAH 2001-10-04

END EXPIRATORY FILTER, MODEL RT020

Applicant Fisher & Paykel Healthcare, Ltd.

K number K002839

View details →

CAH 2001-06-08

AIRLIFE HEPA FILTER

Applicant Allegiance Healthcare Corp.

K number K011132

View details →

CAH 2001-03-09

SLEEVED FILTER

Applicant King Systems Corp.

K number K010040

View details →

CAH 2001-02-05

ELECTROSTATIC HYDROPHOBIC BREATHING FILTER

Applicant Sims Portex, Inc.

K number K002201

View details →

CAH 2000-12-14

BREATHING FILTER FOR DISPOSABLE ANESTHESIA BREATHING CIRCUIT

Applicant Sims Portex, Inc.

K number K002506

View details →

CAH 2000-11-14

VBMAX

Applicant A-M Systems, Inc.

K number K000654

View details →

CAH 1999-06-15

CLEAR-GUARD II, CLEAR-THERM HMEF, CLEAR-THERM HMEF W/ FLEXTUBE, CLEAR GUARD 11 W/ GAS MONITORING PORT

Applicant Intersurgical, Inc.

K number K990949

View details →

CAH 1999-04-30

CLEAR-GUARD MIDI, CLEAR-GUARD MIDI W/FLEXTUBE, CLEAR-THERM MINI, CLEAR-THERM MINI W/FLEXTUBE, MODELS 1644,1644-T,1831,18

Applicant Intersurgical, Inc.

K number K983610

View details →

CAH 1999-03-01

BREATHING CIRCUIT BACTERIAL FILTER/HEAT AND MOISTURE EXCHANGER (HME/F)

Applicant King Systems Corp.

K number K983817

View details →

CAH 1998-09-14

LICHEN, BACTERIAL IN LINE BREATHING FILTER

Applicant Dhd Healthcare Corp.

K number K980662

View details →

CAH 1998-08-14

CIRCUIT GUARD

Applicant Arc Medical, Inc.

K number K982239

View details →

CAH 1998-06-23

POROUS MEDIA DEF25 DISPOSABLE RESPIRATORY FILTER

Applicant Porous Media Corp.

K number K982127

View details →

CAH 1998-03-12

BREATHING CIRCUIT BACTERIAL FILTER

Applicant King Systems Corp.

K number K973797

View details →

CAH 1998-03-11

72 HOUR USE TRACH CARE WITH MICROBAN

Applicant Ballard Medical Products

K number K974630

View details →

CAH 1998-03-11

ZEFON ADULT ANESTHESIA BREATHING CIRCUIT WITH FILTER, ZEFON PEDIATRIC ANESTHESIA BREATHING CIRCUIT WITH FILTER

Applicant Bill Olson Corp.

K number K973238

View details →

CAH 1997-12-02

ISO-GARD FILTER ANGLED(18212)/ISO-GARD FILTER STRAIGHT(19212)

Applicant Gibeck, Inc.

K number K965016

View details →

CAH 1997-11-21

SPIROSAFE FILTER

Applicant Micro Direct, Inc.

K number K973314

View details →

CAH 1997-06-24

FILTER

Applicant Promedic, Inc.

K number K970102

View details →

CAH 1997-04-15

HUMID-VENT FILTER COMPACT ANGLED (18402)/HUMID-VENT FILTER COMPACT STRAIGHT(19402)

Applicant Gibeck, Inc.

K number K964382

View details →

CAH 1997-03-14

POROUS MEDIA DBF23 REUSABLE RESPIRATORY FILTER

Applicant Porous Media Corp.

K number K965020

View details →

CAH 1997-03-11

POROUS MEDIA DBF23 DISPOSABLE RESPIRATORY FILTER

Applicant Porous Media Corp.

K number K964979

View details →

CAH 1997-02-21

9000 SERIES FILTER & FILTER/HME

Applicant Enternet Medical, Inc.

K number K963053

View details →

CAH 1996-11-26

ANESTHESIA BREATHING CIRCUIT/ANESTHESIA BREATHING KIT

Applicant Mallinckrodt Medical

K number K962045

View details →

CAH 1996-11-13

ENGSTROM HMEF 1000

Applicant Datex Engstrom AB

K number K964204

View details →

CAH 1996-10-18

RESPIRGARD II, SPIROGARD

Applicant Marquest Medical Products, Inc.

K number K961838

View details →

CAH 1996-10-03

MERCURY MEDICAL CPR BAG EXHALATION FILTER

Applicant Mercury Medical

K number K954490

View details →

CAH 1996-08-14

BACTERIA/VIRAL FILTER

Applicant Hudson Respiratory Care, Inc.

K number K961914

View details →

CAH 1996-05-02

ISO-GARD HEPA FILTER-HME, ISO-ARD HEPA FILTER-HME W/PORT

Applicant Gibeck, Inc.

K number K954828

View details →

CAH 1995-09-18

WESTMED PEDIATRIC BACTERIAL/VIRAL FILTER

Applicant Westmed Intl.

K number K953687

View details →

CAH 1995-07-07

POROUS MEDIA DBF23-R REUSABLE RESPIRATORY FILTER

Applicant Porous Media Corp.

K number K952428

View details →

CAH 1995-06-08

PFT FILTER

Applicant Intertech Resources, Inc.

K number K952062

View details →

CAH 1995-06-02

BACTERIAL/VIRAL FILTER PRODUCT NUMBERS 5100FILT, 5100THINM, 5100HEPA

Applicant Vital Signs, Inc.

K number K951047

View details →

CAH 1995-05-22

PRIMA FILTER

Applicant Prima, Inc.

K number K952015

View details →

CAH 1995-04-24

WESTMED BACTERIAL/VIRAL FILTER

Applicant Westmed Intl.

K number K951484

View details →

CAH 1995-04-24

DISPOSABLE PULMONARY FUNCTION FILTER

Applicant Creative Biomedics, Inc.

K number K951410

View details →

CAH 1994-11-30

DISPOSABLE BACTERIAL BREATHNG FILTER

Applicant Hospitak, Inc.

K number K915750

View details →

CAH 1994-11-29

GAMGRO ENGSTROM Y FILTER WITH EDITH FLEX (1500 F), EDIT 500, 1000, 2600 AND Y FILTER PACKAGED ALONE

Applicant Intersect Medical Products, Inc.

K number K945543

View details →