FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K991484 |
ALLEGIANCE HEALTHCARE CORP. |
AIRLIFE BUBBLE HUMIDIFER, MODEL 002003 AND 002006 |
05/13/1999 |
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 |
K060790 |
BREAS MEDICAL AB |
BREAS, MODEL HA01 |
05/25/2006 |
K090915 |
CARDINAL HEALTH, INC. |
STERILE WATER FOR INHALATION FLEX BAG, USP |
11/18/2009 |
K160764 |
CAREFUSION 2200, INC. |
AirLife Autofill Humidification Chamber |
08/25/2016 |
K102618 |
DRAEGER MEDICAL AG & CO. KG |
VENTSTAR HEATED, INFINITY ID BREATHING CIRCUIT HEATED |
12/10/2010 |
K953392 |
FISHER & PAYKEL ELECTRONICS LTD. |
HC500 SERVO-CONTROLLED HEATED RESPIRATORY HUMIDIFIER (& ACCESSORIES) |
03/12/1996 |
K162553 |
FISHER & PAYKEL HEALTHCARE |
AirSpiral Heated Breathing Tube |
12/20/2018 |
K220703 |
Fisher & Paykel Healthcare |
F&P 950 Respiratory Humidifier |
06/16/2023 |
K223684 |
Fisher & Paykel Healthcare Ltd |
F&P 820 Humidification System |
09/05/2023 |
K212031 |
Fisher & Paykel Healthcare Ltd |
F&P 850 AirSpiral Adult NIV and NHF Circuit Kit |
04/22/2022 |
K191818 |
Fisher & Paykel Healthcare Ltd |
F&P Optiflow 3S Nasal Cannula (Small, Medium, Large) |
03/19/2020 |
K222197 |
Fisher & Paykel Healthcare Ltd |
F&P Optiflow Junior 2/2+ Nasal Cannula Interface Range |
04/06/2023 |
K143646 |
Fisher & Paykel Healthcare Ltd |
MR810 System, 900MR810 Adult Single Limb Circuit, 900MR810E Adult Dual Limb Circuit |
03/05/2015 |
K201723 |
Fisher & Paykel Healthcare Ltd. |
F&P Optiflow Nasal Oxygen Cannula with CO2 Sampling |
03/16/2021 |
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 |
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 |
K211096 |
Fisher &Paykel Healthcare Ltd. |
Optiflow Oxygen Kit |
01/28/2022 |
K161314 |
FLEXICARE MEDICAL LIMITED |
FLEXICARE FL-9000U RESPIRATORY HUMIDIFIER BASE |
07/06/2016 |
K133766 |
GRUENDLER GMBH |
HUMICARE D900 |
11/24/2014 |
K122705 |
GRUNDLER GMBH |
HUMICARE D900 |
05/21/2013 |
K163283 |
HAMILTON MEDICAL AG |
HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010 |
09/20/2017 |
K152029 |
HAMILTON MEDICAL AG |
HAMILTON-H900, HAMILTON-BC8022, HAMILTON-BC4022, HAMILTON-BC8010, HAMILTON-BC4010 |
05/03/2016 |
K223551 |
Hometa Inc |
Sterile Water for Inhalation in 1L Flexoval « bottles. |
08/03/2023 |
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 |
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 |
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 |
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 |
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 |
K050990 |
MEDICAL INDUSTRIES AMERICA, INC. |
REMREST HEATED HUMIDIFIER |
05/02/2005 |
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 |
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 |
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 |
K193411 |
Perma Pure LLC |
O2asis Personal Oxygen Humidifier |
11/12/2020 |
K062091 |
POROUS MEDIA CORP. |
POROUS MEDIA HUMIDIFLOW HUMIDIFIER FOR UNIVERSAL HUMIDIFICATION |
08/08/2006 |
K971260 |
RESMED CORP. |
SULLIVAN HUMIDAIRE HEATED HUMIDIFIER |
09/04/1997 |
K080797 |
RESMED LTD. |
HUMIDAIRE 2I |
07/09/2008 |
K983862 |
RESPIRATORY SUPPORT PRODUCTS, INC. |
CLOUD 1 HUMIDIFICATION SYSTEM |
05/24/1999 |
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 |
K161719 |
SALTER LABS |
Salter Labs Bubble Humidifier |
09/21/2017 |
K113542 |
SALTER LABS, ARVIN FACILITY |
SALTER LABS BUBBLE HUMIDIFIER (HIGH FLOW) |
02/10/2012 |
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 |
08/01/2014 |
K162242 |
TELEFLEX MEDICAL, INC |
Comfort Flo Humidification System |
01/19/2017 |
K140556 |
TELEFLEX, INC. |
CONCHASMART BREATHING CIRCUIT |
09/24/2014 |
K141940 |
TELEFLEX, INC. |
CONCHASMART COLUMN |
11/24/2014 |
K131912 |
TELEFLEX, INC. |
CONCHATHERM NEPTUNE HEATED HUMIDIFIER, COMFORT FLO HUMIDIFICATION SYSTEM, CONCHASMART COLUMN |
03/06/2014 |
K180474 |
TNI Medical AG |
TNI softFlow 50 |
10/18/2018 |
K203357 |
Vapotherm Inc. |
HVT 2.0 |
08/25/2021 |
K103316 |
VAPOTHERM, INC. |
FLOWREST |
02/08/2011 |
K191010 |
Vapotherm, Inc. |
Palladium High Flow Therapy System |
10/10/2019 |
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 |
K222351 |
Vincent Healthcare Products Limited |
inspiredÖ VHB20 Heated Humidifier |
12/21/2022 |
K002454 |
VITAL SIGNS, INC. |
BREAS HA50 HUMIDIFIER, MODEL HA50 |
03/07/2001 |
K231380 |
Vyaire Medical, Inc. |
AirLife DuoThermÖ Humidification System |
08/10/2023 |