FDA 510(k) Applications for Medical Device Product Code "BTT"
(Humidifier, Respiratory Gas, (Direct Patient Interface))

FDA 510(k) Number Applicant Device Name Decision Date
K842523 3M COMPANY BIRD HEATED HUMIDIFIER 3201 07/11/1984
K780088 3M COMPANY HYMIDIFIER 02/02/1978
K790731 ABBOTT LABORATORIES OXYGEN HUMIDIFIER KIT 05/08/1979
K791683 ABBOTT LABORATORIES STERILE WATER FOR RESPIRATORY THERAPY 09/17/1979
K800056 ABBOTT LABORATORIES VENTILATOR SET 01/24/1980
K863154 ACUTRONIC MEDICAL SYSTEMS AG HEATED JET HUMIDIFIER MODEL AMS-1020 01/12/1987
K802852 AIRLIFE, INC. HUMIDIFIER 02/26/1981
K801252 AIRLIFE, INC. NEBULIZER WITH AIR ENTERTAINER & ETC. 06/04/1980
K991484 ALLEGIANCE HEALTHCARE CORP. AIRLIFE BUBBLE HUMIDIFER, MODEL 002003 AND 002006 05/13/1999
K810939 ALLIED HEALTHCARE PRODUCTS, INC. NEBULIZER/HUMIDIFIER HUMIDITY CENTER-MI. 04/23/1981
K041963 AMERICAN BANTEX CORP. AMERICAN BANTEX HUMIDIFIER, DRY, BUBBLE, MODELS B9000, 3 PSI AND B9100, 6 PSI 10/20/2004
K062664 APEX MEDICAL CORP. HUMIDCARE HEATED HUMIDIFIER, MODEL 9S-004 12/06/2006
K962079 AUTOMATIC LIQUID PACKAGING, INC. HUMIDIFIER ADAPTER 07/31/1996
K920306 AUTOMATIC LIQUID PACKAGING, INC. OPTI-MOL FILTERED PUNCTURE PIN 04/06/1992
K911770 AUTOMATIC LIQUID PACKAGING, INC. OPTIMOL RESPIRATORY HUMIDIFICATION SYSTEM 10/15/1991
K901762 AUTOMATIC LIQUID PACKAGING, INC. PREFILLED FLEXIBLE R.T. CONTAINERS W/STER. SODIUM 07/17/1990
K871618 AUTOMATIC LIQUID PACKAGING, INC. PREFILLED STERILE WATER FOR INHALATION, USP 05/08/1987
K853146 AUTOMATIC LIQUID PACKAGING, INC. RESPIR THER HUMID CONTAIN STERILE WATER FOR USP 08/06/1985
K760587 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC U-MID PREFILLED HUMIDIFIER (300CC) 10/15/1976
K760584 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC U-MID PREFILLED HUMIDIFIER (500CC) 10/15/1976
K873634 BEAR MEDICAL SYSTEMS, INC. BEAR VH-820 HUMIDIFIER 12/02/1987
K896315 BEAR MEDICAL SYSTEMS, INC. BEAR VH820 DISPOSABLE CHAMBER ASSEMBLY 01/22/1990
K842340 BEAR MEDICAL SYSTEMS, INC. VH820 HUMIDIFIER 07/17/1984
K893034 BEAR MEDICAL SYSTEMS, INC. VHS 820 HUMIDIFIER, MODIFICATION 07/14/1989
K781760 BOURNS MEDICAL SYSTEMS, INC. HUMIDIFIERS, MODEL:LS-420 AND LS-460 12/20/1978
K841295 BOW/PARM HYPOTHERMIA OXYGEN WARMER-TREATMENT SYS 08/08/1984
K060790 BREAS MEDICAL AB BREAS, MODEL HA01 05/25/2006
K932570 C.F. ELECTRONICS, INC. MARK I HUMIDIFIER 08/25/1993
K926161 C.F. ELECTRONICS, INC. RES Q AIR SYSTEM MODEL HT-1000 08/26/1993
K812957 CAIRCO LTD. EAST AUTOCLAVE HUMIDIFIER 03/12/1982
K090915 CARDINAL HEALTH, INC. STERILE WATER FOR INHALATION FLEX BAG, USP 11/18/2009
K781537 CHEMETRON MEDICAL PRODUCTS, INC. NEBULIZER/HUMIDIFIER 10/10/1978
K810559 CORPAK CO. OPTI- SYSTEM 03/17/1981
K810219 CORPAK CO. PREFILLED HUMIDIFER 03/04/1981
K831163 CYGNUS RESEARCH CORP. LO-COMP RESERVOIR-RE-1000 05/03/1983
K831556 CYGNUS RESEARCH CORP. VAPOR-PHASE HUMIDIFIER SYSTEM 07/19/1983
K781600 DAVCO MISTY-OX PREFILLED HUMIDIFIER, DISP. 10/31/1978
K881184 DELMED, INC. INTERTECH STERILE WATER FOR INHALATION 05/25/1988
K900602 DEVILBISS HEALTH CARE, INC. DEVILBISS AP-50 COMPRESSOR/NEBULIZER 04/23/1990
K102618 DRAEGER MEDICAL AG & CO. KG VENTSTAR HEATED, INFINITY ID BREATHING CIRCUIT HEATED 12/10/2010
K822816 FISHER & PAYKEL ALLIED PRODUCTS LTD. DUAL SERVO HEATED RESPIRATORY HUMIDIFIER 10/22/1982
K851879 FISHER & PAYKEL ALLIED PRODUCTS LTD. HEATED RESPIRATORY HUMIDIFIER 09/03/1985
K843903 FISHER & PAYKEL ALLIED PRODUCTS LTD. HEATED RESPIRATORY HUMIDIFIER MR428 10/22/1984
K850647 FISHER & PAYKEL ALLIED PRODUCTS LTD. HEATED RESPIRATORY HUMIFIFIER MR440 03/12/1985
K880702 FISHER & PAYKEL ALLIED PRODUCTS LTD. MODEL MR430 SPECIAL PURPOSE HUMID. HEATER BASES 07/08/1988
K863377 FISHER & PAYKEL ALLIED PRODUCTS LTD. MR338 SERVO HEATED DELIVERY HUMIDIFIER 02/20/1987
K872139 FISHER & PAYKEL ALLIED PRODUCTS LTD. MR420 TRANSPORT HUMIDIFIER 09/15/1987
K870055 FISHER & PAYKEL ALLIED PRODUCTS LTD. MR590 DUAL HOSE HEATER POWER PACK 02/10/1987
K862923 FISHER & PAYKEL ALLIED PRODUCTS LTD. MR620 DUAL SERVO HEATED ANAESTHESIA HUMIDIFIER 09/23/1986
K872138 FISHER & PAYKEL ALLIED PRODUCTS LTD. MR630 ENHANCED DUAL SERVO HEATER HUMIDIFIER 10/07/1987
K832928 FISHER & PAYKEL ALLIED PRODUCTS LTD. SERVO HEATED RESPIRATORY HUMIDIFIER 11/25/1983
K953392 FISHER & PAYKEL ELECTRONICS LTD. HC500 SERVO-CONTROLLED HEATED RESPIRATORY HUMIDIFIER (& ACCESSORIES) 03/12/1996
K892817 FISHER & PAYKEL ELECTRONICS LTD. HEATED RESPIRATORY HUMIDIFIER 12/21/1989
K915460 FISHER & PAYKEL ELECTRONICS LTD. HEATED RESPIRATORY HUMIDIFIER HC100 01/15/1993
K913367 FISHER & PAYKEL ELECTRONICS LTD. MODELS MR410 & MR480 RESPIRATORY HUMIDIFIER/ACCESS 06/25/1992
K913368 FISHER & PAYKEL ELECTRONICS LTD. MODELS MR700/MR720/MR730 DUAL SERVO RESP HUMID ACC 01/13/1992
K934140 FISHER & PAYKEL ELECTRONICS LTD. MR290 HUMIDIFICATION CHAMBER SINGLE USE 01/24/1994
K143646 Fisher & Paykel Healthcare Ltd MR810 System, 900MR810 Adult Single Limb Circuit, 900MR810E Adult Dual Limb Circuit 3/5/2015
K131895 FISHER & PAYKEL HEALTHCARE, LTD. AIRVO 2 HUMIDIFIER, MYAIRVO 2 HUMIDIFIER 10/24/2013
K121975 FISHER & PAYKEL HEALTHCARE, LTD. AIRVO HUMIDIFIER MYAIRO HUMIDIFIER 01/03/2013
K092846 FISHER & PAYKEL HEALTHCARE, LTD. AIRVO SERIES HUMIDIFIERS 01/27/2010
K132017 FISHER & PAYKEL HEALTHCARE, LTD. HC550 RESPIRATORY HUMIDIFIER, ADULT VENTILATOR CIRCUIT 03/25/2014
K881970 FISHER & PAYKEL HEALTHCARE, LTD. MODEL MR2000 HEATED RESPIRATORY HUMIDIFIER 03/09/1989
K131957 FISHER & PAYKEL HEALTHCARE, LTD. MR810RESPIRATORY HUMIDIFIER, 900MR810 ADULT SINGLE LIMB CIRCUIT, 900MR810E ADULT DUAL LIMB CIRCUIT 12/04/2013
K033710 FISHER & PAYKEL HEALTHCARE, LTD. MR850 RESPIRATORY HUMIDIFIER, MODEL MR850JHU 04/13/2004
K110019 FISHER & PAYKEL HEALTHCARE, LTD. RESPIRATORY HUMIDIFER 03/30/2012
K100554 FISHER & PAYKEL HEALTHCARE, LTD. RESPIRATORY HUMIDIFIER , HEATED DELIVERY SYSTEM, ADAPTOR, MODELS MR880, RT241, 900MR441 05/28/2010
K983112 FISHER & PAYKEL HEALTHCARE, LTD. RESPIRATORY HUMIDIFIER, MODEL # MR850 11/10/1998
K003973 FISHER & PAYKEL HEALTHCARE, LTD. RESPIRATORY HUMIDIFIER, MODEL HC150 06/01/2001
K020332 FISHER & PAYKEL HEALTHCARE, LTD. RESPIRATORY HUMIDIFIER, MODEL MR850 07/07/2003
K073706 FISHER & PAYKEL HEALTHCARE, LTD. RESPIRATORY HUMIDIFIER, MODEL MR850 03/31/2008
K760566 FOREGGER AIR PRODUCTS & CHEM., INC. PREFILLED HUMIDIFIER 10/15/1976
K133766 GRUENDLER GMBH HUMICARE D900 11/24/2014
K122705 GRUNDLER GMBH HUMICARE D900 05/21/2013
K761293 HARRIS-LAKE, INC. RESPIRATORY HUMIDIFIER 01/03/1977
K760372 HOSPITEK HUMIDIFIER, DISPOSABLE 08/13/1976
K841851 HPD MEDICAL, INC. HPD HUMIDIFIER WICK 06/05/1984
K864173 HPD MEDICAL, INC. HPD HUMIDIFYING CHAMBER 01/30/1987
K885314 HPD MEDICAL, INC. HPD STERILE HUMIDIFYING CHAMBER 01/17/1989
K993773 HUDSON RCJ AB HUMID-HEAT 09/13/2000
K001213 HUDSON RESPIRATORY CARE, INC. CONCHATHERM 2000 HUMIDIFICATION SYSTEM, MODELS 500-00, -10, -20, -30, -40, -50, & -60 11/03/2000
K923946 HUDSON RESPIRATORY CARE, INC. CONCHATHERM IV HEATED MOLECULAR HUMIDIFIER 10/18/1994
K993355 HUDSON RESPIRATORY CARE, INC. HUDSON RCI CONCHA COLUMN, CAT. NO. 385-40 AND HUDSON RCI CIRCUIT, CAT. NO. 780-40, 780-41, 780-42, 780-43 05/24/2000
K031383 HUDSON RESPIRATORY CARE, INC. MODEL 780 07/07/2003
K010402 HUDSON RESPIRATORY CARE, INC. SMOOTH-FLO CIRCUIT 03/14/2001
K993282 I.P.I. MEDICAL PRODUCTS IPI HUMIDIFIER CHAMBER 09/18/2000
K874659 INHALATION PLASTICS STERILIZATION OF DEVICES BY RADIATION 02/02/1988
K914686 INHALATION PLASTICS THERMO-FLOW SET 04/15/1992
K760037 INSPIRON CORP. HEATER, IMMERSION W/ HUMIDIFIER & NEBUL. 07/16/1976
K841158 INSPIRON CORP. NEBULO 28 NEBULIZER KIT 03/30/1984
K843932 INSPIRON CORP. VAPOR-PHASE HUMIDIFIER SYS-ADVANCED 10/18/1984
K882582 INTERTECH RESOURCES, INC. STERILE INHALATION WATER TRANSFER SET 09/30/1988
K003561 INVACARE CORP. INVACARE PASSOVER HUMIDIFIER MODEL ISP9700 04/17/2001
K031176 INVACARE CORP. INVACARE POLARIS EX HEATED HUMIDIFIER, MODEL ISP4000 03/25/2004
K990614 KING SYSTEMS CORP. HME-BOOSTER 05/23/2000
K893122 LIFETRONICS, INC. HEATED SERVO HUMIDIFIER, MODEL HDS 2 10/20/1989
K770415 M.G. HUMIDIFIERS, INC. HUMIDIFIER, DISPOSABLE 04/07/1977
K993268 MALLINCKRODT DAR S.R.L. MALLINCKRODT DAR HEATED WIRE BREATHING CIRCUIT 04/19/2000
K042184 MALLINCKRODT DEVELOPPEMENT FRANCE GOODKNIGHT H20, MODEL M-114600-00 01/10/2005
K880979 MARQUEST MEDICAL PRODUCTS, INC. MARQUEST SCT 2000, HEATED HUMIDIFICATION SYSTEM 07/15/1988
K903138 MARQUEST MEDICAL PRODUCTS, INC. MARQUEST SCT 3000, HEATED HUMIDIFICATION SYSTEM 10/11/1990
K970478 MARQUEST MEDICAL PRODUCTS, INC. SCT 3000 HEATED HUMIDIFIER 07/16/1997
K962223 MARQUEST MEDICAL PRODUCTS, INC. WATER CHAMBERS FOR ST 3000 HEATED HUMIDIFIER 01/14/1997
K870173 MAUNA LOA MEDICAL, INC. LAVABED SYSTEM & CHAMBER, LAVAPAK TEMP. CONTROL 04/03/1987
K050990 MEDICAL INDUSTRIES AMERICA, INC. REMREST HEATED HUMIDIFIER 05/02/2005
K923754 MEDICAL MOLDING CORP. OF AMERICA MISTY OX LAMINAR DIFFUSER HUMIDIFIER 12/07/1992
K052615 MEDISIZE BV MEDISIZE GOLD 12/09/2005
K070714 MEDISIZE BV MEDISIZE GOLD HEATER AND BOOSTER 04/30/2007
K122885 MEDISIZE BV MEDISIZE GOLD HEATER AND BOOSTER T-PIECE 08/29/2013
K830913 MEDLOG GMBH MARKETING SERVICES MINITROP AEROSAL, PRODOMO AEROSAL AND 05/25/1983
K900569 MERCED MEDICAL, INC. THERMOPROBE 210 04/10/1990
K801619 MISTOGEN EQUIPMENT CO. MIST2GEN TEMPTROL 10 08/04/1980
K792620 MODERN MEDICAL SYSTEMS CO. NEONATAL HEATED HUMIDIFIER 01/24/1980
K842794 NOVA-VENTRX MAXI-MISER HUMIDIFIER INSERT 1020 & 1021 10/04/1984
K842795 NOVA-VENTRX MAXI-MISER HUMIDIFIER INSERT 1030 10/04/1984
K080149 PACIFIC MEDICO CO., LTD. HEATER BASE, MODEL PMH7000 12/18/2008
K132857 PACIFIC MEDICO CO., LTD. RESPIRATORY GAS HUMIDIFIER 05/01/2014
K070107 PARI INNOVATIVE MANUFACTURERS, INC. PARI HYDRATE G 02/23/2007
K072982 PARI INNOVATIVE MANUFACTURERS, INC. PARI HYDRATE V 11/29/2007
K915890 PEGASUS RESEARCH CORP. AUTOCLAVABLE THERA-MIST HUMIDIFIER P3600, MODIFIED 06/24/1992
K983783 PEGASUS RESEARCH CORP. HEATED HUMIDIFIER 10/24/2000
K013856 PEGASUS RESEARCH CORP. PMH 1000 HEATED HUMIDIFIER 02/21/2003
K020700 PEGASUS RESEARCH CORP. PMH 5000 HEATED HUMIDIFIER FOR RESPIRATORY THERAPY 04/26/2004
K894000 PEGASUS RESEARCH CORP. THERA-MIST HUMIDIFIER 08/28/1989
K062091 POROUS MEDIA CORP. POROUS MEDIA HUMIDIFLOW HUMIDIFIER FOR UNIVERSAL HUMIDIFICATION 08/08/2006
K902970 PRECISION MEDICAL, INC. PRECISION MEDICAL DISPOSABLE HUMIDIFIER 08/14/1990
K760923 PURITAN BENNETT CORP. HUMIDIFIER-CASCADE II 11/19/1976
K936000 PURITAN BENNETT CORP. PURITAN-BENNETT CASCADE I SERIES HUMIDIFIER MODIFICATION 08/15/1994
K820878 RCI, INC. CONCHO PEDIATRIC PACK 05/03/1982
K950582 RESCARE, INC. SULLIVAN PASSOVER HUMIDIFER 09/15/1995
K971260 RESMED CORP. SULLIVAN HUMIDAIRE HEATED HUMIDIFIER 09/04/1997
K080797 RESMED LTD. HUMIDAIRE 2I 07/09/2008
K811073 RESPIRATORY CARE, INC. A QUAPAK 04/29/1981
K833974 RESPIRATORY CARE, INC. AQUAPAK 020 HUMIDIFIER ADAPTER 12/16/1983
K780562 RESPIRATORY CARE, INC. AQUAPAK PREFILLED HUMIDIFIER 04/27/1978
K863955 RESPIRATORY CARE, INC. COLBY LEVEL ALARM 11/07/1986
K760866 RESPIRATORY CARE, INC. CONCHA-COLUMN 11/01/1976
K780845 RESPIRATORY CARE, INC. CONCHANEOPAK A CARTRIDGE HUMIDIFIER 08/14/1978
K834151 RESPIRATORY CARE, INC. CONCHATHERM LHF HUMIDIFIER HEATER 01/13/1984
K884150 RESPIRATORY CARE, INC. MODIFIED CONCHATHERM III CONTROLLED HEATER 11/21/1988
K983862 RESPIRATORY SUPPORT PRODUCTS, INC. CLOUD 1 HUMIDIFICATION SYSTEM 05/24/1999
K873472 RESPIRATORY SUPPORT PRODUCTS, INC. MEMBRANE HUMIDIFIER 01/19/1988
K030090 RESPIRONICS, INC. H2 HEATED HUMIDIFIER 01/24/2003
K945782 RESPIRONICS, INC. HUMIDIFIER 03/01/1996
K964653 RESPIRONICS, INC. OASIS HUMIDIFIER 02/14/1997
K012633 RESPIRONICS, INC. RESPIRONICS HEATED HUMIDIFIER 02/28/2002
K113542 SALTER LABS, ARVIN FACILITY SALTER LABS BUBBLE HUMIDIFIER (HIGH FLOW) 02/10/2012
K854363 SARATOGA MEDICAL INSTRUMENTATION, INC. SARATOGA SCT HEATED HUMIDIFICATION SYSTEM 12/31/1985
K823143 SEVEN HARVEST INTL. IMPORT & EXPORT BUBBLE HUMIDIFIERS 11/29/1982
K963025 SLEEPNET CORPORATION SLEEPNET HUMIDIFIER,(84200 PACKAGED) 11/01/1996
K050314 SMITHS MEDICAL ASD, INC. AQUINOX 02/18/2005
K092256 SMITHS MEDICAL ASD, INC. THERA- HEAT HEATED HUMIDIFIER, MODEL RC70000, RC70072, RC70075, RC70077, RC70012 10/20/2010
K071958 SMITHS MEDICAL ASD, INC. THERA-HEAT HEATED HUMIDIFIER AND ADULT DUAL AND SINGLE LIMB HEATED WIRE VENTILATOR BREATHING CIRCUITS 11/21/2007
K131388 SOMNETICS INTERNATIONAL, INC. TRANSCEND HEATED HUMIDIFIER 09/26/2013
K003626 SUNRISE MEDICAL HHG, INC. DEVILBISS HUMIDIFIER 05/04/2001
K020900 SUNRISE MEDICAL HHG, INC. DEVILBISS MODEL 9200D HEATED HUMIDIFIER SYSTEM 06/03/2002
K031179 TAGA MEDICAL TECHNOLOGIES, INC. TAGA VELOCITY HUMIDIFIER 07/17/2003
K010578 TAGA MEDICAL TECHNOLOGIES, INC. TAGA VELOCITY PASSOVER HUMIDIFIER UNIT, MODEL MP1017 04/25/2001
K040507 TAGA MEDICAL TECHNOLOGIES, INC. TAGA VELOCITY PASSOVER HUMIDIFIER WITH HEATER, MODEL TM1000H 03/04/2004
K063758 TELEFLEX MEDICAL CHONCHA THERM NEPTUNE HEATED HUMIFIER, CHONCHA THERM NEPTUNE HEATED HUMIFIER (REMANUFACTURER), MODEL# 425-00,425-00R 04/23/2007
K061736 TELEFLEX MEDICAL COMFORT FLO HUMIDIFICATION SYSTEM AND NASAL CANNULA 08/18/2006
K141353 TELEFLEX MEDICAL , INC. HUDSON RCI AQUAPAK HUMIDIFIER ADAPTOR 8/1/2014
K140556 TELEFLEX, INC. CONCHASMART BREATHING CIRCUIT 9/24/2014
K141940 TELEFLEX, INC. CONCHASMART COLUMN 11/24/2014
K131912 TELEFLEX, INC. CONCHATHERM NEPTUNE HEATED HUMIDIFIER, COMFORT FLO HUMIDIFICATION SYSTEM, CONCHASMART COLUMN 03/06/2014
K900854 THE JOHN BUNN CO. JOHN BUNN: "MEDIX COMPACT TRAVELLER" 04/23/1990
K802145 TRAVENOL LABORATORIES, S.A. 2C 7140 HEATED HUMIDIFER CANNISTER 09/26/1980
K802144 TRAVENOL LABORATORIES, S.A. 2M8101 HEATED LIQUID LEVEL CONTROLLER 09/26/1980
K781468 TRAVENOL LABORATORIES, S.A. CONTINUOUS FEED VALVE 2D9024 09/07/1978
K760938 TRAVENOL LABORATORIES, S.A. DISPOSABLE HUMIDIFIER 11/09/1976
K780381 TRAVENOL LABORATORIES, S.A. RESPIRATORY THERAPY SOLUTIONS - FLEXIBLE 05/16/1978
K780385 TRAVENOL LABORATORIES, S.A. RESPIRATORY THERAPY SOLUTIONS - FLEXIBLE 05/16/1978
K800753 TRAVENOL LABORATORIES, S.A. STERILE WATER & SALINE IN PLASTIC BTL. 04/24/1980
K851940 TRAVENOL LABORATORIES, S.A. STERILE WATER FOR INHALATION USP 2D0799 06/20/1985
K770249 TRAVENOL LABORATORIES, S.A. VENTILATOR SET - CODE 2C7109 02/14/1977
K103316 VAPOTHERM, INC. FLOWREST 02/08/2011
K072845 VAPOTHERM, INC. PRECISION FLOW 07/17/2008
K111640 VAPOTHERM, INC. PRECISION FLOW(R) - HELIOX 10/07/2011
K070056 VAPOTHERM, INC. VAPOTHERM MODEL# 2000I AND 2000H 04/13/2007
K013486 VAPOTHERM, INC. VAPOTHERM 2000H 05/30/2003
K042245 VAPOTHERM, INC. VAPOTHERM MODEL#2000I, 200H 08/30/2004
K000401 VAPOTHERM, INC. VAPOTHERM, MODEL 2000I 08/24/2000
K093617 VENTLAB CORP. VENTLAB 6000 SERIES HUMIDIFIER 01/27/2011
K002454 VITAL SIGNS, INC. BREAS HA50 HUMIDIFIER, MODEL HA50 03/07/2001


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