FDA 510(k) Applications for Medical Device Product Code "CAH"
(Filter, Bacterial, Breathing-Circuit)

FDA 510(k) Number Applicant Device Name Decision Date
K760611 3M COMPANY 3M BRAND ANESTHESIA FILTER,#3110 09/21/1976
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
K772047 AMERICAN HOSPITAL SUPPLY CORP. RESPIRATORY KIT 11/23/1977
K850265 AMERICAN PHARMASEAL DIV. AHSC AMERICAN TWA WAY FILTER -BACTERIAL/VIRAL-RETENTIVE 04/05/1985
K944189 ANETEC, INC. TRANSPARENT ANESTHESIA FILTER 10/28/1994
K892520 ARBO MEDICAL, INC. BREATHING CIRCUIT BACTERIAL FILTERS 08/02/1989
K901816 ARBO MEDICAL, INC. PRESSURE TUBING AND ACCESSORIES 07/12/1990
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
K760041 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC FILTER, RESPIRATORY (U-MID) 07/16/1976
K973238 BILL OLSON CORP. ZEFON ADULT ANESTHESIA BREATHING CIRCUIT WITH FILTER, ZEFON PEDIATRIC ANESTHESIA BREATHING CIRCUIT WITH FILTER 03/11/1998
K911651 BILL OLSON CORP. ZEFON BATERIAL/VIRAL FILTER 05/30/1991
K934189 BIRD LIFE DESIGN BARRIERFLEX-I, AND BARRIERFLES-II 11/24/1993
K934540 BIRD LIFE DESIGN BARRIERFLEX-PF PULMONARY FUNCTION TESTING FILTER 10/19/1993
K896116 CADEMA MEDICAL PRODUCTS, INC. ENTRAPPING FILTER 11/17/1989
K901476 CADEMA MEDICAL PRODUCTS, INC. MODIFIED ENTRAPPING FILTER 05/01/1990
K111408 CAREFUSION GERMANY 234 GMBH MICROGARD II 10/17/2011
K951410 CREATIVE BIOMEDICS, INC. DISPOSABLE PULMONARY FUNCTION FILTER 04/24/1995
K770375 CUTTER LABORATORIES, INC. FILTER, AIR, CUTTER MAINLINE 03/01/1977
K770376 CUTTER LABORATORIES, INC. FILTER, NEBULIZER, CUTTER 03/01/1977
K770392 CUTTER LABORATORIES, INC. MUFFLER, AIR PUMP 03/07/1977
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
K792097 DRYDEN CORP. DRYDEN BACTERIA FILTER 11/13/1979
K833066 DRYDEN CORP. DRYDEN MINI BACTERIA FILTER 10/28/1983
K840205 DRYDEN CORP. DRYDEN MINI BACTERIA FILTER 02/04/1984
K841581 DUPACO, INC. UNIFILTER ANESTHESIA & RESPIRATORY FILT 04/30/1984
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
K821310 ESP PLASTICS, INC. ESPREE' ANESTHESIA BACTERIAL FILTER 06/11/1982
K131626 EXCELERON MEDICAL EXCELERON BACTERIAL FILTERS 02/26/2014
K895233 F.L.W. PLASTICS, INC. BACTERIAL AND VIRAL FILTER 11/15/1989
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
K163300 Flexicare Medical Limited ThermoShield HME Filter 03/22/2017
K092218 FLEXICARE MEDICAL LTD. FLEXICARE BREATHING FILTERS 10/06/2009
K760567 FOREGGER AIR PRODUCTS & CHEM., INC. BACTERIA FILTER 09/15/1976
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
K832935 GISH BIOMEDICAL, INC. GASLINE FILTER, #EC-GLF SERIES 11/22/1983
K101629 GLENN MEDICAL SYSTEMS, INC. FIL 1520 07/09/2010
K812098 HEALTHCARE IND. MINI NICHOLES 08/18/1981
K812075 HEALTHCARE IND. NICHOLE'S "99 08/12/1981
K915750 HOSPITAK, INC. DISPOSABLE BACTERIAL BREATHNG FILTER 11/30/1994
K091185 HSINER CO., LTD. 70530-BACTIAL/VIRAL FILTER, 70531-HMEF, 70536-BACTERIAL/VIRAL FILTER 07/24/2009
K890035 HUDSON OXYGEN THERAPY SALES CO. BACTERIA FILTER 05/05/1989
K780535 HUDSON OXYGEN THERAPY SALES CO. HUMIDIFIER FILTER 04/27/1978
K961914 HUDSON RESPIRATORY CARE, INC. BACTERIA/VIRAL FILTER 08/14/1996
K842580 INFRASONICS CORP. ACCESSORY FOR ADULT VOL. VENTILATOR 08/24/1984
K896832 INHALATION PLASTICS FILT-R-ALL BACTERIAL FILTER 01/22/1990
K900990 INHALATION PLASTICS FILT-R-ALL BACTERIAL/VIRAL FILTER 04/19/1990
K760081 INSPIRON CORP. FILTER, BACTERIA (#2290) 07/15/1976
K945543 INTERSECT MEDICAL PRODUCTS, INC. GAMGRO ENGSTROM Y FILTER WITH EDITH FLEX (1500 F), EDIT 500, 1000, 2600 AND Y FILTER PACKAGED ALONE 11/29/1994
K141087 INTERSURGICAL INCORPORATED INTER-THERM PEDIATRIC HMEF, INTERN-THERM MINI PEDIATRIC ANGLED HMEF 02/12/2015
K911427 INTERSURGICAL, INC. BREATHING FILTERS 08/26/1991
K925462 INTERSURGICAL, INC. BREATHING FILTERS 1942T/1941T/2014T 05/21/1993
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
K930816 INTERTECH RESOURCES, INC. HEPA FILTERED HME 07/01/1993
K952062 INTERTECH RESOURCES, INC. PFT FILTER 06/08/1995
K883693 INTERTECH RESOURCES, INC. RESUSCITATION BAG EXHALATION FILTER 09/30/1988
K890346 INTERTECH/OHIO INTERTECH UNIVERSAL HYDROPHOBIC FILTER 03/01/1989
K811546 K & G HEALTHCARE IND., INC. NICHOLAS II, VIRAL-BACTERIAL FILTER 08/03/1981
K812573 K & G HEALTHCARE IND., INC. SPIROMETER FILTER 10/23/1981
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
K880681 KING SYSTEMS CORP. MINI-FILTER, VIROBAC II 04/29/1988
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
K893030 LIFE DESIGN SYSTEMS, INC. CHILD SIZE - FILTER FLEX (TM) 09/18/1989
K841236 LIFE DESIGN SYSTEMS, INC. FILTER-FLEX 04/05/1984
K925388 LIFE SHIELD HEALTHCARE PRODUCTS, INC. LIFE SHIELD HEALTHCARE PRODUCTS BREATHING FILTER 05/11/1993
K802914 LIFECARE SERVICES, INC. 6-435 FILTER PAD, 5/PKG. 12/19/1980
K880958 LIFEGUARD MEDICAL PRODUCTS, INC. LIFEGUARD BACTERIAL AND VIRAL FILTER 04/27/1988
K931842 MAG, INC. BREATHING FILTER 05/19/1993
K962045 MALLINCKRODT MEDICAL ANESTHESIA BREATHING CIRCUIT/ANESTHESIA BREATHING KIT 11/26/1996
K941536 MALLINCKRODT MEDICAL BARRIERBAC AND BARRIERBAC "S" 04/19/1994
K941381 MALLINCKRODT MEDICAL HYGROBAC,"S" HYGROBOY AND HYGROBABY 04/15/1994
K944124 MALLINCKRODT MEDICAL SPIROBAC ADAPTERS 09/08/1994
K941676 MALLINCKRODT MEDICAL STERIVENT AND STERIVENT "S" 05/20/1994
K030071 MAQUET, INC. SERVO GUARD, MODEL 64 81 290 EH88E 04/26/2004
K833269 MARQUEST MEDICAL PRODUCTS, INC. RESPIR GARD BACTERIA FILTER 10/31/1983
K833267 MARQUEST MEDICAL PRODUCTS, INC. RESPIR GARD-II OXYGARD HYDROGARD-SPIRO 10/28/1983
K802763 MARQUEST MEDICAL PRODUCTS, INC. RESPIRGARD 11/26/1980
K961838 MARQUEST MEDICAL PRODUCTS, INC. RESPIRGARD II, SPIROGARD 10/18/1996
K930760 MED-PLASTICS INTL., INC. MED-PLASTICS INTL., INC. BREATHING FILTER 03/11/1993
K894978 MED-TEK CORP. BACTERIAL FILTER 11/02/1989
K911738 MEDICAL ASSEMBLIES, INC. MEDICAL ASSEMBLIES FILTER 07/11/1991
K851070 MEDICOMP, INC. RESP-BAC BACTERIA FILTER 06/14/1985
K853577 MEDIPART JERRY ALEXANDER MEDIPART BACTERIA FILTER MP-2615 10/30/1985
K844492 MEDIPART JERRY ALEXANDER MEDIPART BACTERIA FILTER MP-30X 12/04/1984
K844491 MEDIPART JERRY ALEXANDER MEDIPART FILTER & TUBING MP-02X 12/04/1984
K862789 MEDIPART JERRY ALEXANDER MP-01X DISPOSABLE BACTERIA FILTER KIT 08/01/1986
K862790 MEDIPART JERRY ALEXANDER MP-01X-I DISPOSABLE FILTER KIT 08/01/1986
K862785 MEDIPART JERRY ALEXANDER MP-1204 DISPOSABLE BACTERIA FILTER 08/01/1986
K862787 MEDIPART JERRY ALEXANDER MP-2831 DISPOSABLE CONDUCTIVE BREATHING FILTER 08/01/1986
K862786 MEDIPART JERRY ALEXANDER MP-50T DISPOSABLE BREATHING CIRCUIT FILTER 08/01/1986
K081536 MEDISIZE BV MEDISIZE BLUE, MEDISIZE GREEN, MEDISIZE RED 01/23/2009
K954490 MERCURY MEDICAL MERCURY MEDICAL CPR BAG EXHALATION FILTER 10/03/1996
K925217 MERIT MEDICAL SYSTEMS, INC. MERIDIAN MEDICAL SYSTEMS BREATHING FILTER 01/26/1993
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
K830618 OHIO MEDICAL PRODUCTS BREATHING FILTER 04/08/1983
K823257 OHIO MEDICAL PRODUCTS NON-REUSABLE UNIVERSAL NEBULIZER FILTE 12/09/1982
K781696 OLYMPIC MEDICAL CORP. COPPER-TRAP 11/03/1978
K801804 OMNICON MEDICAL CORP. ANESTHESIA BACTERIA FILTER 08/13/1980
K820577 OMNICON MEDICAL CORP. ANESTHESIA BACTERIA FILTER 03/18/1982
K770136 OMNICON MEDICAL CORP. DISPOSABLE BACTERIA FILTER 02/14/1977
K801803 OMNICON MEDICAL CORP. MAINFLOW BACTERIA FILTER 08/13/1980
K820576 OMNICON MEDICAL CORP. MAINFLOW BACTERIA FILTER 03/18/1982
K850327 PALL BIOMEDICAL PRODUCTS CO. PALL GAS LINE GUARDIAN FILTER 02/26/1985
K840960 PALL BIOMEDICAL PRODUCTS CO. PALL COALESCER 03/16/1984
K791307 PALL BIOMEDICAL PRODUCTS CO. UNIPOR BREATHING CIRCUIT FILTER 08/03/1979
K013093 PALL MEDICAL PALL ULTIPOR ANESTHESIA BREATHING SYSTEM 08/01/2002
K093426 PHARMA SYSTEMS AB BACT-TRAP HEPA MIDI 02/22/2010
K903056 PHARMA SYSTEMS, INC. BACTTRAP 11/05/1990
K790896 PHARMASEAL DIV., BAXTER HEALTHCARE CORP. TWO-WAY ANESTHESIA FILTER 06/05/1979
K791773 PHARMASEAL DIV., BAXTER HEALTHCARE CORP. VENTILATOR TUBE WITH FILTER 10/22/1979
K061426 POROUS MEDIA CORP. OXYGEN CONCENTRATOR FILTERS, MODELS DBF32, DBF24, DBF27, DBF25, DFC06 AND DDF47 06/05/2006
K934132 POROUS MEDIA CORP. POROUS MEDIA DBF23 DISPOSABLE RESPIRATORY FILTER 10/04/1994
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
K952428 POROUS MEDIA CORP. POROUS MEDIA DBF23-R REUSABLE RESPIRATORY FILTER 07/07/1995
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
K943874 PRECISION THERMOPLASTIC COMPONENTS, INC. PRECISON THERMOPLASTIC COMPONENTS GAS AMPLING LINES AND CONNECTORS 10/28/1994
K952015 PRIMA, INC. PRIMA FILTER 05/22/1995
K970102 PROMEDIC, INC. FILTER 06/24/1997
K934475 PULMONARY DATA SERVICES INST., INC. KOKO FILTER II 10/21/1993
K890362 PURITAN BENNETT CORP. OMNIFILTER MAIN FLOW BACTERIA FILTER 03/14/1989
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
K892230 RESPIRATORY CARE, INC. RCI VIRAL/BACTERIAL FILTER 08/28/1989
K934509 SDI DIAGNOSTICS, INC. PULMOGUARD DISPOSABLE BATERIAL/VIRAL FILTER 10/21/1993
K934272 SENSORMEDICS CORP. SENSORMEDICS MICROGARD MICROBIAL FILTER 11/24/1993
K871366 SIEMENS ELEMA AB SIEMENS MAIN FLOW BACTERIA FILTER 05/14/1987
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
K922492 SPECIALTY PACKAGING PRODUCS, INC. SPECIALTY PACKAGING PROD BACTERIAL/VIRAL FILTER 08/24/1992
K884465 SPIROMETRICS, INC. SPIROMETRICS MODEL 2141 SPIRO-FILTER(TM) 11/09/1988
K102483 SUNSET HEALTHCARE SOLUTIONS, LLC SUNSET HEALTHCARE SOLUTIONS BACTERIAL/VIRAL HME FILTER, MODEL BHF 104 09/13/2011
K931217 TEKNOR MEDICAL PRODUCTS, INC. BREATHING FILTER 04/23/1993
K112958 TELEFLEX MEDICAL HUMID-VENT HEPA 09/21/2012
K021020 TERUMO CARDIOVASCULAR SYSTEMS CORP. TERUMO GAS FILTER 06/10/2002
K864103 THE KENDAL CO. CURITY ANESTHESIA FILTER 01/28/1987
K923661 UNION BROACH, DIV. MOYCO INDUSTRIES, INC. QUADRASORB FILTER 10/20/1992
K030271 VENTLAB CORP. VENTLAB BACTERIAL FILTER, MODEL BF100 07/07/2003
K904830 VITAL SIGNS, INC. BACTERIA FILTER 04/10/1991
K912577 VITAL SIGNS, INC. BACTERIA FILTER 04/22/1992
K951047 VITAL SIGNS, INC. BACTERIAL/VIRAL FILTER PRODUCT NUMBERS 5100FILT, 5100THINM, 5100HEPA 06/02/1995
K831856 VITAL SIGNS, INC. BREATHING CIRCUIT BACTERIA FILTER 09/26/1983
K920885 VITAL SIGNS, INC. VENTILATOR CIRCUITS 10/23/1992
K132709 VR MEDICAL VR MEDICAL HEAT AND MOISTURE EXCHANGER AND FILTER 07/30/2014
K951484 WESTMED INTL. WESTMED BACTERIAL/VIRAL FILTER 04/24/1995
K953687 WESTMED INTL. WESTMED PEDIATRIC BACTERIAL/VIRAL FILTER 09/18/1995
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


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact