| HVT 2.0 (K254078) | Vapotherm, Inc. | 2026-04-13 |
| FL-10000U Respiratory Humidifier (K251448) | Flexicare Medical Limited. | 2026-01-16 |
| Laboratorios Biogalenic Sterile Water for Inhalation, USP (K251419) | Laboratorios Biogalenic S.A. DE C.V. | 2026-01-14 |
| Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J) (K253479) | Fisher & Paykel Healthcare, Ltd. | 2025-12-19 |
| Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus and Soft Plus Cannula Extra Small (K250312) | Medline Industries, LP | 2025-07-02 |
| 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 (MYOPT9LARGE) (K251611) | Fisher & Paykel Healthcare, Ltd. | 2025-06-25 |
| Laboratorios Biogalenic Sterile Water for Inhalation, USP (K242717) | Laboratorios Biogalenic S.A. DE C.V. | 2025-01-30 |
| Hudson RCI Comfort Flo® CubCannula™ (K241778) | Medline Industries, LP | 2024-12-19 |
| Hudson RCI® Comfort Flo Nasal Cannula; Hudson RCI® Comfort Flo Plus Cannula (K240163) | Medline Industries, LP | 2024-09-27 |
| F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility (AA041J) (K234058) | Fisher & Paykel Healthcare, Ltd. | 2024-08-08 |
| HFT150 (K233707) | Invent Medical Corporation | 2024-06-14 |
| F&P Optiflow Oxygen Kit (AA451J) (K233821) | Fisher & Paykel Healthcare, Ltd. | 2024-06-13 |
| F&P myAirvo 3 (K222292) | Fisher & Paykel Healthcare | 2024-05-08 |
| F&P Optiflow+ Duet Nasal Cannula (K231956) | Fisher & Paykel Healthcare, Ltd. | 2024-02-07 |
| Hudson RCI® Disposable Humidifier with 4 PSI Pressure Relief Valve (3230), Hudson RCI® Disposable Humidifier with 6 PSI Pressure Relief Valve (3260) (K230559) | Medline Industries, Inc. | 2023-10-26 |
| BONHAWA Respiratory Humidifier (K223863) | Telesair, Inc. | 2023-10-13 |
| F&P 820 Humidification System (K223684) | Fisher & Paykel Healthcare, Ltd. | 2023-09-05 |
| AirLife DuoTherm™ Humidification System (K231380) | Vyaire Medical, Inc. | 2023-08-10 |
| Sterile Water for Inhalation in 1L Flexoval ® bottles. (K223551) | Hometa, Inc. | 2023-08-03 |
| F&P 950 Respiratory Humidifier (K220703) | Fisher & Paykel Healthcare | 2023-06-16 |
| F&P Optiflow Junior 2/2+ Nasal Cannula Interface Range (K222197) | Fisher & Paykel Healthcare, Ltd. | 2023-04-06 |
| inspired™ VHB20 Heated Humidifier (K222351) | Vincent Healthcare Products Limited | 2022-12-21 |
| F&P 850 AirSpiral Adult NIV and NHF Circuit Kit (K212031) | Fisher & Paykel Healthcare, Ltd. | 2022-04-22 |
| Optiflow Oxygen Kit (K211096) | Fisher & Paykel Healthcare, Ltd. | 2022-01-28 |
| HVT 2.0 (K203357) | Vapotherm, Inc. | 2021-08-25 |
| F&P Optiflow Nasal Oxygen Cannula with CO2 Sampling (K201723) | Fisher & Paykel Healthcare, Ltd. | 2021-03-16 |
| O2asis Personal Oxygen Humidifier (K193411) | Perma Pure, LLC | 2020-11-12 |
| F&P Optiflow 3S Nasal Cannula (Small, Medium, Large) (K191818) | Fisher & Paykel Healthcare, Ltd. | 2020-03-19 |
| Palladium High Flow Therapy System (K191010) | Vapotherm, Inc. | 2019-10-10 |
| AirSpiral Heated Breathing Tube (K162553) | Fisher & Paykel Healthcare | 2018-12-20 |
| TNI softFlow 50 (K180474) | Tni Medical AG | 2018-10-18 |
| Salter Labs Bubble Humidifier (K161719) | Salter Labs | 2017-09-21 |
| HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010 (K163283) | Hamilton Medical AG | 2017-09-20 |
| Comfort Flo Humidification System (K162242) | Teleflexmedical, Inc. | 2017-01-19 |
| AirLife Autofill Humidification Chamber (K160764) | Carefusion 2200, Inc. | 2016-08-25 |
| FLEXICARE FL-9000U RESPIRATORY HUMIDIFIER BASE (K161314) | Flexicare Medical Limited. | 2016-07-06 |
| HAMILTON-H900, HAMILTON-BC8022, HAMILTON-BC4022, HAMILTON-BC8010, HAMILTON-BC4010 (K152029) | Hamilton Medical AG | 2016-05-03 |
| MR810 System, 900MR810 Adult Single Limb Circuit, 900MR810E Adult Dual Limb Circuit (K143646) | Fisher & Paykel Healthcare, Ltd. | 2015-03-05 |
| CONCHASMART COLUMN (K141940) | Teleflex, Inc. | 2014-11-24 |
| HUMICARE D900 (K133766) | Gruendler GmbH | 2014-11-24 |
| CONCHASMART BREATHING CIRCUIT (K140556) | Teleflex, Inc. | 2014-09-24 |
| HUDSON RCI AQUAPAK HUMIDIFIER ADAPTOR (K141353) | Teleflexmedical, Inc. | 2014-08-01 |
| RESPIRATORY GAS HUMIDIFIER (K132857) | Pacific Medico Co., Ltd. | 2014-05-01 |
| HC550 RESPIRATORY HUMIDIFIER, ADULT VENTILATOR CIRCUIT (K132017) | Fisher & Paykel Healthcare, Ltd. | 2014-03-25 |
| CONCHATHERM NEPTUNE HEATED HUMIDIFIER, COMFORT FLO HUMIDIFICATION SYSTEM, CONCHASMART COLUMN (K131912) | Teleflex, Inc. | 2014-03-06 |
| MR810RESPIRATORY HUMIDIFIER, 900MR810 ADULT SINGLE LIMB CIRCUIT, 900MR810E ADULT DUAL LIMB CIRCUIT (K131957) | Fisher & Paykel Healthcare, Ltd. | 2013-12-04 |
| AIRVO 2 HUMIDIFIER, MYAIRVO 2 HUMIDIFIER (K131895) | Fisher & Paykel Healthcare, Ltd. | 2013-10-24 |
| TRANSCEND HEATED HUMIDIFIER (K131388) | Somnetics International, Inc. | 2013-09-26 |
| MEDISIZE GOLD HEATER AND BOOSTER T-PIECE (K122885) | Medisize BV | 2013-08-29 |
| HUMICARE D900 (K122705) | Grundler GmbH | 2013-05-21 |
| AIRVO HUMIDIFIER MYAIRO HUMIDIFIER (K121975) | Fisher & Paykel Healthcare, Ltd. | 2013-01-03 |
| RESPIRATORY HUMIDIFER (K110019) | Fisher & Paykel Healthcare, Ltd. | 2012-03-30 |
| SALTER LABS BUBBLE HUMIDIFIER (HIGH FLOW) (K113542) | Salter Labs, Arvin Facility | 2012-02-10 |
| PRECISION FLOW(R) - HELIOX (K111640) | Vapotherm, Inc. | 2011-10-07 |
| FLOWREST (K103316) | Vapotherm, Inc. | 2011-02-08 |
| VENTLAB 6000 SERIES HUMIDIFIER (K093617) | Ventlab Corp. | 2011-01-27 |
| VENTSTAR HEATED, INFINITY ID BREATHING CIRCUIT HEATED (K102618) | Draeger Medical AG & Co. KG | 2010-12-10 |
| THERA- HEAT HEATED HUMIDIFIER, MODEL RC70000, RC70072, RC70075, RC70077, RC70012 (K092256) | Smiths Medical Asd, Inc. | 2010-10-20 |
| RESPIRATORY HUMIDIFIER , HEATED DELIVERY SYSTEM, ADAPTOR, MODELS MR880, RT241, 900MR441 (K100554) | Fisher & Paykel Healthcare, Ltd. | 2010-05-28 |
| AIRVO SERIES HUMIDIFIERS (K092846) | Fisher & Paykel Healthcare, Ltd. | 2010-01-27 |
| STERILE WATER FOR INHALATION FLEX BAG, USP (K090915) | Cardinal Health, Inc. | 2009-11-18 |
| HEATER BASE, MODEL PMH7000 (K080149) | Pacific Medico Co., Ltd. | 2008-12-18 |
| PRECISION FLOW (K072845) | Vapotherm, Inc. | 2008-07-17 |
| HUMIDAIRE 2I (K080797) | Resmed, Ltd. | 2008-07-09 |
| RESPIRATORY HUMIDIFIER, MODEL MR850 (K073706) | Fisher & Paykel Healthcare, Ltd. | 2008-03-31 |
| PARI HYDRATE V (K072982) | Pari Innovative Manufacturers, Inc. | 2007-11-29 |
| THERA-HEAT HEATED HUMIDIFIER AND ADULT DUAL AND SINGLE LIMB HEATED WIRE VENTILATOR BREATHING CIRCUITS (K071958) | Smiths Medical Asd, Inc. | 2007-11-21 |
| MEDISIZE GOLD HEATER AND BOOSTER (K070714) | Medisize BV | 2007-04-30 |
| CHONCHA THERM NEPTUNE HEATED HUMIFIER, CHONCHA THERM NEPTUNE HEATED HUMIFIER (REMANUFACTURER), MODEL# 425-00,425-00R (K063758) | Teleflex Medical | 2007-04-23 |
| VAPOTHERM MODEL# 2000I AND 2000H (K070056) | Vapotherm, Inc. | 2007-04-13 |
| PARI HYDRATE G (K070107) | Pari Innovative Manufacturers, Inc. | 2007-02-23 |
| HUMIDCARE HEATED HUMIDIFIER, MODEL 9S-004 (K062664) | Apex Medical Corp. | 2006-12-06 |
| COMFORT FLO HUMIDIFICATION SYSTEM AND NASAL CANNULA (K061736) | Teleflex Medical | 2006-08-18 |
| POROUS MEDIA HUMIDIFLOW HUMIDIFIER FOR UNIVERSAL HUMIDIFICATION (K062091) | Porous Media Corp. | 2006-08-08 |
| BREAS, MODEL HA01 (K060790) | Breas Medical AB | 2006-05-25 |
| MEDISIZE GOLD (K052615) | Medisize BV | 2005-12-09 |
| REMREST HEATED HUMIDIFIER (K050990) | Medical Industries America, Inc. | 2005-05-02 |
| AQUINOX (K050314) | Smiths Medical Asd, Inc. | 2005-02-18 |
| GOODKNIGHT H20, MODEL M-114600-00 (K042184) | Mallinckrodt Developpement France | 2005-01-10 |
| AMERICAN BANTEX HUMIDIFIER, DRY, BUBBLE, MODELS B9000, 3 PSI AND B9100, 6 PSI (K041963) | American Bantex Corp. | 2004-10-20 |
| VAPOTHERM MODEL#2000I, 200H (K042245) | Vapotherm, Inc. | 2004-08-30 |
| PMH 5000 HEATED HUMIDIFIER FOR RESPIRATORY THERAPY (K020700) | Pegasus Research Corp. | 2004-04-26 |
| MR850 RESPIRATORY HUMIDIFIER, MODEL MR850JHU (K033710) | Fisher & Paykel Healthcare, Ltd. | 2004-04-13 |
| INVACARE POLARIS EX HEATED HUMIDIFIER, MODEL ISP4000 (K031176) | Invacare Corp. | 2004-03-25 |
| TAGA VELOCITY PASSOVER HUMIDIFIER WITH HEATER, MODEL TM1000H (K040507) | Taga Medical Technologies, Inc. | 2004-03-04 |
| TAGA VELOCITY HUMIDIFIER (K031179) | Taga Medical Technologies, Inc. | 2003-07-17 |
| MODEL 780 (K031383) | Hudson Respiratory Care, Inc. | 2003-07-07 |
| RESPIRATORY HUMIDIFIER, MODEL MR850 (K020332) | Fisher & Paykel Healthcare, Ltd. | 2003-07-07 |
| VAPOTHERM 2000H (K013486) | Vapotherm, Inc. | 2003-05-30 |
| PMH 1000 HEATED HUMIDIFIER (K013856) | Pegasus Research Corp. | 2003-02-21 |
| H2 HEATED HUMIDIFIER (K030090) | Respironics, Inc. | 2003-01-24 |
| DEVILBISS MODEL 9200D HEATED HUMIDIFIER SYSTEM (K020900) | Sunrise Medical Hhg, Inc. | 2002-06-03 |
| RESPIRONICS HEATED HUMIDIFIER (K012633) | Respironics, Inc. | 2002-02-28 |
| RESPIRATORY HUMIDIFIER, MODEL HC150 (K003973) | Fisher & Paykel Healthcare, Ltd. | 2001-06-01 |
| DEVILBISS HUMIDIFIER (K003626) | Sunrise Medical Hhg, Inc. | 2001-05-04 |
| TAGA VELOCITY PASSOVER HUMIDIFIER UNIT, MODEL MP1017 (K010578) | Taga Medical Technologies, Inc. | 2001-04-25 |
| INVACARE PASSOVER HUMIDIFIER MODEL ISP9700 (K003561) | Invacare Corp. | 2001-04-17 |
| SMOOTH-FLO CIRCUIT (K010402) | Hudson Respiratory Care, Inc. | 2001-03-14 |
| BREAS HA50 HUMIDIFIER, MODEL HA50 (K002454) | Vital Signs, Inc. | 2001-03-07 |
| CONCHATHERM 2000 HUMIDIFICATION SYSTEM, MODELS 500-00, -10, -20, -30, -40, -50, & -60 (K001213) | Hudson Respiratory Care, Inc. | 2000-11-03 |