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 |
| 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 |
| K222292 | Fisher & Paykel Healthcare | F&P myAirvo 3 | 05/08/2024 |
| 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 |
| K234058 | Fisher & Paykel Healthcare Ltd | F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility (AA041J) | 08/08/2024 |
| K222197 | Fisher & Paykel Healthcare Ltd | F&P Optiflow Junior 2/2+ Nasal Cannula Interface Range | 04/06/2023 |
| K233821 | Fisher & Paykel Healthcare Ltd | F&P Optiflow Oxygen Kit (AA451J) | 06/13/2024 |
| K231956 | Fisher & Paykel Healthcare Ltd | F&P Optiflow+ Duet Nasal Cannula | 02/07/2024 |
| K143646 | Fisher & Paykel Healthcare Ltd | MR810 System, 900MR810 Adult Single Limb Circuit, 900MR810E Adult Dual Limb Circuit | 03/05/2015 |
| K251611 | Fisher & Paykel Healthcare Ltd | Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium (OPT944); Optiflow+ Nasal Cannula - Large (OPT946); Optiflow+ Nasal Cannula Small (MYOPT9SMALL); Optiflow+ Nasal Cannula Medium (MYOPT9MEDIUM); Optiflow+ Nasal Cannula Large (MYOP | 06/25/2025 |
| 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 |
| K233707 | Invent Medical Corporation | HFT150 | 06/14/2024 |
| K990614 | KING SYSTEMS CORP. | HME-BOOSTER | 05/23/2000 |
| K242717 | Laboratorios Biogalenic, S.A. DE C.V. | Laboratorios Biogalenic Sterile Water for Inhalation, USP | 01/30/2025 |
| 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 |
| K230559 | Medline Industries, Inc. | Hudson RCI« Disposable Humidifier with 4 PSI Pressure Relief Valve (3230), Hudson RCI« Disposable Humidifier with 6 PSI Pressure Relief Valve (3260) | 10/26/2023 |
| K241778 | Medline Industries, LP. | Hudson RCI Comfort Flo« CubCannulaÖ | 12/19/2024 |
| K250312 | Medline Industries, LP. | Hudson RCI« Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI« Comfort Flo Plus and Soft Plus Cannula Extra Small | 07/02/2025 |
| K240163 | Medline Industries, LP. | Hudson RCI« Comfort Flo Nasal Cannula; Hudson RCI« Comfort Flo Plus Cannula | 09/27/2024 |
| 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 |
| K223863 | Telesair, Inc. | BONHAWA Respiratory Humidifier | 10/13/2023 |
| 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 |
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