FDA 510(k) Applications for Medical Device Product Code "CAH"
(Filter, Bacterial, Breathing-Circuit)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K130664 | A-M SYSTEMS | HYRDROMAX HMEF | 06/21/2013 |
| K063526 | A-M SYSTEMS, INC. | A-M SYSTEMS VIROMAX VIRAL AND BACTERIAL FILTER | 06/29/2007 |
| K000654 | A-M SYSTEMS, INC. | VBMAX | 11/14/2000 |
| K052087 | AG INDUSTRIES | BREATHING FILTER BACTERIAL/VIRAL, MODEL AG7178 | 12/14/2005 |
| K091363 | AG INDUSTRIES | COMPRESSOR FILTER, MODELS AG1038831, HCF100,BF900,BF910,BF950, LL201, LL202, LL205, BACTERIA FILTER | 02/04/2010 |
| K033008 | AIR SAFETY LTD | AIR SAFETY HEPA AND NON-HEPA FILTERS | 05/13/2004 |
| K050953 | AIR SAFETY LTD | AIR SAFETY MODEL 3000/06 FILTER HEPA REUSABLE | 06/29/2005 |
| K011132 | ALLEGIANCE HEALTHCARE CORP. | AIRLIFE HEPA FILTER | 06/08/2001 |
| K043148 | ALLIANCE TECH MEDICAL, INC. | ALL FLOW PULMONARY FUNCTION FILTER | 12/13/2004 |
| K982239 | ARC MEDICAL, INC. | CIRCUIT GUARD | 08/14/1998 |
| K011212 | ARC MEDICAL, INC. | FILTERFLO H | 12/20/2001 |
| K063125 | ARC MEDICAL, INC. | FILTERFLO HEPA; THERMOFLO HEPA (FILTER / HME) | 04/13/2007 |
| K090738 | ARC MEDICAL, INC. | THERMOFLO HCH, THERMOFLO FILTER | 07/27/2009 |
| K974630 | BALLARD MEDICAL PRODUCTS | 72 HOUR USE TRACH CARE WITH MICROBAN | 03/11/1998 |
| K973238 | BILL OLSON CORP. | ZEFON ADULT ANESTHESIA BREATHING CIRCUIT WITH FILTER, ZEFON PEDIATRIC ANESTHESIA BREATHING CIRCUIT WITH FILTER | 03/11/1998 |
| K111408 | CAREFUSION GERMANY 234 GMBH | MICROGARD II | 10/17/2011 |
| K964204 | DATEX ENGSTROM AB | ENGSTROM HMEF 1000 | 11/13/1996 |
| K021265 | DATEX-OHMEDA | DATEX-OHMEDA HMEF 500 | 08/30/2002 |
| K031653 | DATEX-OHMEDA | DATEX-OHMEDA HMEF 750 | 06/20/2003 |
| K023641 | DATEX-OHMEDA | DATEX-OHMEDA HMEF MINI | 11/27/2002 |
| K030990 | DATEX-OHMEDA | DATEX-OHMEDA MINI-FILTER/S AND UNI-FILTER JUNIOR | 06/25/2003 |
| K043120 | DATEX-OHMEDA, INC. | MIN-FILTER/S, UNI-FILTER JUNIOR, UNI-FILTER/S ANGLED AND UNI-FILTER | 03/01/2005 |
| K980662 | DHD HEALTHCARE CORP. | LICHEN, BACTERIAL IN LINE BREATHING FILTER | 09/14/1998 |
| K072002 | DRAEGER MEDICAL AG & CO. KG | FILTER CARESTAR 30; FILTER SAFESTAR 55; FILTER/HME TWINSTAR 55 | 01/31/2008 |
| K221836 | DrΣgerwerk AG & Co. KGaA | Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus | 12/07/2022 |
| K012958 | EMERGENCY FILTRATION PRODUCTS, INC. | BREATHING CIRCUIT FILTER | 02/22/2002 |
| K013122 | ENGINEERED MEDICAL SYSTEMS | EMS ELECTROSTATIC FLITER AND HME COMBINATION | 04/19/2002 |
| K013089 | ENGINEERED MEDICAL SYSTEMS | EMS HEPA FILTER AND HME COMBINATIONS | 03/14/2002 |
| K963053 | ENTERNET MEDICAL, INC. | 9000 SERIES FILTER & FILTER/HME | 02/21/1997 |
| K131626 | EXCELERON MEDICAL | EXCELERON BACTERIAL FILTERS | 02/26/2014 |
| K133666 | FISHER & PAYKEL HEALTHCARE LTD. | RT016 INSPIRATORY FILTER | 02/05/2014 |
| K002839 | FISHER & PAYKEL HEALTHCARE, LTD. | END EXPIRATORY FILTER, MODEL RT020 | 10/04/2001 |
| K050927 | FISHER & PAYKEL HEALTHCARE, LTD. | RT019 INSPIRATORY/EXPIRATORY FILTER | 08/01/2005 |
| K191909 | Flexicare Medical Limited | HepaShield Bacterial Viral Breathing System Filter | 03/23/2020 |
| K163300 | Flexicare Medical Limited | ThermoShield HME Filter | 03/22/2017 |
| K092218 | FLEXICARE MEDICAL LTD. | FLEXICARE BREATHING FILTERS | 10/06/2009 |
| K132679 | GALEMED CORP. | AF VIRAL/BACTERIAL FILTER, BF VIRAL/BACTERIAL FILTER | 04/18/2014 |
| K964382 | GIBECK, INC. | HUMID-VENT FILTER COMPACT ANGLED (18402)/HUMID-VENT FILTER COMPACT STRAIGHT(19402) | 04/15/1997 |
| K965016 | GIBECK, INC. | ISO-GARD FILTER ANGLED(18212)/ISO-GARD FILTER STRAIGHT(19212) | 12/02/1997 |
| K954828 | GIBECK, INC. | ISO-GARD HEPA FILTER-HME, ISO-ARD HEPA FILTER-HME W/PORT | 05/02/1996 |
| K101629 | GLENN MEDICAL SYSTEMS, INC. | FIL 1520 | 07/09/2010 |
| K210352 | Great Group Medical Co., Ltd. | GGM Breathing Circuit Bacterial Filter | 03/27/2022 |
| K091185 | HSINER CO., LTD. | 70530-BACTIAL/VIRAL FILTER, 70531-HMEF, 70536-BACTERIAL/VIRAL FILTER | 07/24/2009 |
| K961914 | HUDSON RESPIRATORY CARE, INC. | BACTERIA/VIRAL FILTER | 08/14/1996 |
| K141087 | INTERSURGICAL INCORPORATED | INTER-THERM PEDIATRIC HMEF, INTERN-THERM MINI PEDIATRIC ANGLED HMEF | 02/12/2015 |
| K223258 | Intersurgical Ltd. | TNI Clear-GuardÖ 3 angled breathing filter (1545020) | 06/15/2023 |
| K990949 | INTERSURGICAL, INC. | CLEAR-GUARD II, CLEAR-THERM HMEF, CLEAR-THERM HMEF W/ FLEXTUBE, CLEAR GUARD 11 W/ GAS MONITORING PORT | 06/15/1999 |
| K983610 | INTERSURGICAL, INC. | CLEAR-GUARD MIDI, CLEAR-GUARD MIDI W/FLEXTUBE, CLEAR-THERM MINI, CLEAR-THERM MINI W/FLEXTUBE, MODELS 1644,1644-T,1831,18 | 04/30/1999 |
| K024270 | INTERSURGICAL, INC. | CLEAR-THERM 3 HMEF, CLEAR-THERM 3 WITH SUPERSET CATHETER MOUNT,CLEAR-THERM WITH FLEXIBLE CATHETER MOUNT,CLEAR-GUARD 3 F3 | 06/24/2003 |
| K032322 | INTERSURGICAL, INC. | CLEAR-THERM MICRO HME, MODEL 1441 | 05/13/2004 |
| K121026 | INTERSURGICAL, INC. | FLO-GUARD BREATHING FILTER | 11/02/2012 |
| K092409 | INTERSURGICAL, INC. | HYDRO-GUARD MINI BREATHING FILTER AND HEAT AND MOISTURE EXCHANGER AND AIR-GUARD CLEAR BREATHING FILTER | 03/10/2010 |
| K092451 | INTERSURGICAL, INC. | INTERSURGICAL INTER-THERM BREATHING FILTER AND HEAT AND MOISTURE EXCHANGER, INTERSURGICAL INTER-GUARD BREATHING FILTER | 10/29/2010 |
| K973797 | KING SYSTEMS CORP. | BREATHING CIRCUIT BACTERIAL FILTER | 03/12/1998 |
| K983817 | KING SYSTEMS CORP. | BREATHING CIRCUIT BACTERIAL FILTER/HEAT AND MOISTURE EXCHANGER (HME/F) | 03/01/1999 |
| K012485 | KING SYSTEMS CORP. | MS-140 ALL-ROUND ENHANCED PERFORMANCE FILTER; MS-141 ALL-ROUND ENHANCED PERFORMANCE ANGLED; MS-142 ALL-ROUND/HME ENHANCE | 10/09/2001 |
| K010040 | KING SYSTEMS CORP. | SLEEVED FILTER | 03/09/2001 |
| K032878 | KUNG SHIN PLASTICS CO., LTD. | KUNG SHIN, HMEF SK203 | 09/20/2004 |
| K962045 | MALLINCKRODT MEDICAL | ANESTHESIA BREATHING CIRCUIT/ANESTHESIA BREATHING KIT | 11/26/1996 |
| K182862 | Maquet Critical Care AB | Servo Guard | 10/21/2019 |
| K030071 | MAQUET, INC. | SERVO GUARD, MODEL 64 81 290 EH88E | 04/26/2004 |
| K961838 | MARQUEST MEDICAL PRODUCTS, INC. | RESPIRGARD II, SPIROGARD | 10/18/1996 |
| K190022 | MD Diagnostics Limited | SafeBreath Filter Mouthpiece | 09/25/2019 |
| K081536 | MEDISIZE BV | MEDISIZE BLUE, MEDISIZE GREEN, MEDISIZE RED | 01/23/2009 |
| K192713 | Meditera Tibbi Malzeme San. ve Tic. A.S. | Altera Filter and HME/Filter | 03/16/2020 |
| K954490 | MERCURY MEDICAL | MERCURY MEDICAL CPR BAG EXHALATION FILTER | 10/03/1996 |
| K973314 | MICRO DIRECT, INC. | SPIROSAFE FILTER | 11/21/1997 |
| K014282 | MUNKTELL FILTER AB | BACSTOP FILTER,BACSTOP FILTER/HME | 06/26/2002 |
| K014281 | MUNKTELL FILTER AB | GARD FILTER, COMBIGARD FILTE / HME | 06/26/2002 |
| K221250 | NDD Medizintechnik AG | EasyOne Filter | 11/22/2022 |
| K221472 | Ningbo Huakun Medical Equipment Co., Ltd. | Filter and HME/Filter | 02/08/2023 |
| K211286 | Pall Corporation | Ultipor U55/U55N Breathing Circuit Filter and Heat and Moisture Exchanger | 11/16/2021 |
| K013093 | PALL MEDICAL | PALL ULTIPOR ANESTHESIA BREATHING SYSTEM | 08/01/2002 |
| K230483 | Passy-Muir, Inc. | Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15) | 09/16/2023 |
| K202459 | Pharma System AB | Bact-Trap Filter, Bact-Trap Mini, Bact-Trap Midi, Pharma Mini HME/Filter, Bact-HME HME/Filter and Bact-HME Midi HME/Filter | 09/26/2021 |
| K093426 | PHARMA SYSTEMS AB | BACT-TRAP HEPA MIDI | 02/22/2010 |
| K061426 | POROUS MEDIA CORP. | OXYGEN CONCENTRATOR FILTERS, MODELS DBF32, DBF24, DBF27, DBF25, DFC06 AND DDF47 | 06/05/2006 |
| K964979 | POROUS MEDIA CORP. | POROUS MEDIA DBF23 DISPOSABLE RESPIRATORY FILTER | 03/11/1997 |
| K965020 | POROUS MEDIA CORP. | POROUS MEDIA DBF23 REUSABLE RESPIRATORY FILTER | 03/14/1997 |
| K982127 | POROUS MEDIA CORP. | POROUS MEDIA DEF25 DISPOSABLE RESPIRATORY FILTER | 06/23/1998 |
| K032716 | PORTEX LTD. | PORTEX THERMOVENT HEPA HME BREATHING FILTER WITH CO2 PORT (STERILE AND NON-STERILE) | 11/28/2003 |
| K970102 | PROMEDIC, INC. | FILTER | 06/24/1997 |
| K110246 | QSERVE AMERICA, INC. | MEDISIZE RED AND MEDISIZE BLUE | 11/04/2011 |
| K013200 | RENNELS MEDICAL CORP. | RENMED CONTAMI-SHIELD BREATHING CIRCUIT SLEEVE, MODEL 9999/01 | 12/14/2001 |
| K002506 | SIMS PORTEX, INC. | BREATHING FILTER FOR DISPOSABLE ANESTHESIA BREATHING CIRCUIT | 12/14/2000 |
| K002201 | SIMS PORTEX, INC. | ELECTROSTATIC HYDROPHOBIC BREATHING FILTER | 02/05/2001 |
| K102483 | SUNSET HEALTHCARE SOLUTIONS, LLC | SUNSET HEALTHCARE SOLUTIONS BACTERIAL/VIRAL HME FILTER, MODEL BHF 104 | 09/13/2011 |
| K112958 | TELEFLEX MEDICAL | HUMID-VENT HEPA | 09/21/2012 |
| K021020 | TERUMO CARDIOVASCULAR SYSTEMS CORP. | TERUMO GAS FILTER | 06/10/2002 |
| K030271 | VENTLAB CORP. | VENTLAB BACTERIAL FILTER, MODEL BF100 | 07/07/2003 |
| K132709 | VR MEDICAL | VR MEDICAL HEAT AND MOISTURE EXCHANGER AND FILTER | 07/30/2014 |
| K121382 | Westmed, Inc. | WESTMED, INC.'S BLOCKAIDE FILTER [21 CFR 807.87(A)] | 12/06/2012 |
| K151498 | ZHEJIANG HAISHENG MEDICAL DEVICE CO., LTD. | Breathing circuit bacterial/viral filter | 12/18/2015 |
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