Humidifier, Respiratory Gas, (Direct Patient Interface)
FDA product code BTT · Class II (moderate risk) · 21 CFR 868.5450 · Anesthesiology
222510(k) clearances
0PMA approvals
62recalls
Manufacturers
- Fisher & Paykel Healthcare, Ltd. 28
- Fisher & Paykel Allied Products , Ltd. 11
- Vapotherm, Inc. 10
- Travenol Laboratories, S.A. 9
- Respiratory Care, Inc. 8
- Automatic Liquid Packaging, Inc. 6
- Fisher & Paykel Electronics , Ltd. 6
- Pegasus Research Corp. 5
- Hudson Respiratory Care, Inc. 5
- Bear Medical Systems, Inc. 4
- Medline Industries, LP 4
- Marquest Medical Products, Inc. 4
- Respironics, Inc. 4
- Inspiron Corp. 3
- Smiths Medical ASD Inc. 3
- Hpd Medical, Inc. 3
- Abbott Laboratories 3
- Teleflex LLC 3
- Medisize BV 3
- Taga Medical Technologies, Inc. 3
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262268 | Optiflow Oxygen Kit (AA484J)BTT · Special | Fisher and Paykel Healthcare Limited | 08/27/2026SE |
| K254078 | HVT 2.0BTT · Traditional | Vapotherm, Inc. | 04/13/2026SE |
| K251448 | FL-10000U Respiratory HumidifierBTT · Traditional | Flexicare Medical Limited. | 01/16/2026SE |
| K251419 | Laboratorios Biogalenic Sterile Water for Inhalation, USPBTT · Traditional | Laboratorios Biogalenic S.A. DE C.V. | 01/14/2026SE |
| K253479 | Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J)BTT · Special | Fisher & Paykel Healthcare, Ltd. | 12/19/2025SE |
| K250312 | Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus…BTT · Traditional | Medline Industries, LP | 07/02/2025SE |
| K251611 | Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium (OPT944)…BTT · Special | Fisher & Paykel Healthcare, Ltd. | 06/25/2025SE |
| K242717 | Laboratorios Biogalenic Sterile Water for Inhalation, USPBTT · Traditional | Laboratorios Biogalenic S.A. DE C.V. | 01/30/2025SE |
| K241778 | Hudson RCI Comfort Flo® CubCannulaBTT · Traditional | Medline Industries, LP | 12/19/2024SE |
| K240163 | Hudson RCI® Comfort Flo Nasal Cannula; Hudson RCI® Comfort Flo Plus CannulaBTT · Traditional | Medline Industries, LP | 09/27/2024SE |
| K234058 | F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility (AA041J)BTT · Traditional | Fisher & Paykel Healthcare, Ltd. | 08/08/2024SE |
| K233707 | HFT150BTT · Traditional | Invent Medical Corporation | 06/14/2024SE |
| K233821 | F&P Optiflow Oxygen Kit (AA451J)BTT · Traditional | Fisher & Paykel Healthcare, Ltd. | 06/13/2024SE |
| K222292 | F&P myAirvo 3BTT · Traditional | Fisher & Paykel Healthcare | 05/08/2024SE |
| K231956 | F&P Optiflow+ Duet Nasal CannulaBTT · Traditional | Fisher & Paykel Healthcare, Ltd. | 02/07/2024SE |
| K230559 | Hudson RCI® Disposable Humidifier with 4 PSI Pressure Relief Valve (3230), Hudson RCI®…BTT · Traditional | Medline Industries, Inc. | 10/26/2023SE |
| K223863 | BONHAWA Respiratory HumidifierBTT · Traditional | Telesair, Inc. | 10/13/2023SE |
| K223684 | F&P 820 Humidification SystemBTT · Traditional | Fisher & Paykel Healthcare, Ltd. | 09/05/2023SE |
| K231380 | AirLife DuoTherm Humidification SystemBTT · Traditional | Vyaire Medical, Inc. | 08/10/2023SE |
| K223551 | Sterile Water for Inhalation in 1L Flexoval ® bottles.BTT · Traditional | Hometa, Inc. | 08/03/2023SE |
| K220703 | F&P 950 Respiratory HumidifierBTT · Traditional | Fisher & Paykel Healthcare | 06/16/2023SE |
| K222197 | F&P Optiflow Junior 2/2+ Nasal Cannula Interface RangeBTT · Traditional | Fisher & Paykel Healthcare, Ltd. | 04/06/2023SE |
| K222351 | inspired VHB20 Heated HumidifierBTT · Traditional | Vincent Healthcare Products Limited | 12/21/2022SE |
| K212031 | F&P 850 AirSpiral Adult NIV and NHF Circuit KitBTT · Traditional | Fisher & Paykel Healthcare, Ltd. | 04/22/2022SE |
| K211096 | Optiflow Oxygen KitBTT · Traditional | Fisher & Paykel Healthcare, Ltd. | 01/28/2022SE |
| K203357 | HVT 2.0BTT · Traditional | Vapotherm, Inc. | 08/25/2021SE |
| K201723 | F&P Optiflow Nasal Oxygen Cannula with CO2 SamplingBTT · Traditional | Fisher & Paykel Healthcare, Ltd. | 03/16/2021SE |
| K193411 | O2asis Personal Oxygen HumidifierBTT · Traditional | Perma Pure, LLC | 11/12/2020SE |
| K191818 | F&P Optiflow 3S Nasal Cannula (Small, Medium, Large)BTT · Traditional | Fisher & Paykel Healthcare, Ltd. | 03/19/2020SE |
| K191010 | Palladium High Flow Therapy SystemBTT · Traditional | Vapotherm, Inc. | 10/10/2019SE |
| K162553 | AirSpiral Heated Breathing TubeBTT · Traditional | Fisher & Paykel Healthcare | 12/20/2018SE |
| K180474 | TNI softFlow 50BTT · Traditional | Tni Medical AG | 10/18/2018SE |
| K161719 | Salter Labs Bubble HumidifierBTT · Traditional | Salter Labs | 09/21/2017SE |
| K163283 | HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010BTT · Traditional | Hamilton Medical AG | 09/20/2017SE |
| K162242 | Comfort Flo Humidification SystemBTT · Traditional | Teleflexmedical, Inc. | 01/19/2017SE |
| K160764 | AirLife Autofill Humidification ChamberBTT · Traditional | Carefusion 2200, Inc. | 08/25/2016SE |
| K161314 | Flexicare FL-9000U Respiratory Humidifier BaseBTT · Traditional | Flexicare Medical Limited. | 07/06/2016SE |
| K152029 | HAMILTON-H900, HAMILTON-BC8022, HAMILTON-BC4022, HAMILTON-BC8010, HAMILTON-BC4010BTT · Traditional | Hamilton Medical AG | 05/03/2016SE |
| K143646 | MR810 System, 900MR810 Adult Single Limb Circuit, 900MR810E Adult Dual Limb CircuitBTT · Traditional | Fisher & Paykel Healthcare, Ltd. | 03/05/2015SE |
| K141940 | Conchasmart ColumnBTT · Traditional | Teleflex, Inc. | 11/24/2014SE |
| K133766 | Humicare D900BTT · Traditional | Gruendler GmbH | 11/24/2014SE |
| K140556 | Conchasmart Breathing CircuitBTT · Traditional | Teleflex, Inc. | 09/24/2014SE |
| K141353 | Hudson Rci Aquapak Humidifier AdaptorBTT · Special | Teleflexmedical, Inc. | 08/01/2014SE |
| K132857 | Respiratory Gas HumidifierBTT · Special | Pacific Medico Co., Ltd. | 05/01/2014SE |
| K132017 | HC550 Respiratory Humidifier, Adult Ventilator CircuitBTT · Traditional | Fisher & Paykel Healthcare, Ltd. | 03/25/2014SE |
| K131912 | Conchatherm Neptune Heated Humidifier, Comfort Flo Humidification System, Conchasmart…BTT · Traditional | Teleflex, Inc. | 03/06/2014SE |
| K131957 | MR810RESPIRATORY Humidifier, 900MR810 Adult Single Limb Circuit, 900MR810E Adult Dual…BTT · Traditional | Fisher & Paykel Healthcare, Ltd. | 12/04/2013SE |
| K131895 | Airvo 2 Humidifier, Myairvo 2 HumidifierBTT · Traditional | Fisher & Paykel Healthcare, Ltd. | 10/24/2013SE |
| K131388 | Transcend Heated HumidifierBTT · Traditional | Somnetics International, Inc. | 09/26/2013SE |
| K122885 | Medisize Gold Heater and Booster T-PieceBTT · Traditional | Medisize BV | 08/29/2013SE |
| K122705 | Humicare D900BTT · Traditional | Grundler GmbH | 05/21/2013SE |
| K121975 | Airvo Humidifier Myairo HumidifierBTT · Traditional | Fisher & Paykel Healthcare, Ltd. | 01/03/2013SE |
| K110019 | Respiratory HumidiferBTT · Traditional | Fisher & Paykel Healthcare, Ltd. | 03/30/2012SE |
| K113542 | Salter Labs Bubble Humidifier (High Flow)BTT · Traditional | Salter Labs, Arvin Facility | 02/10/2012SE |
| K111640 | Precision Flow(R) - HelioxBTT · Traditional | Vapotherm, Inc. | 10/07/2011SE |
| K103316 | FlowrestBTT · Traditional | Vapotherm, Inc. | 02/08/2011SE |
| K093617 | Ventlab 6000 Series HumidifierBTT · Traditional | Ventlab Corp. | 01/27/2011SE |
| K102618 | Ventstar Heated, Infinity Id Breathing Circuit HeatedBTT · Traditional | Draeger Medical AG & Co. KG | 12/10/2010SE |
| K092256 | Thera- Heat Heated Humidifier, Model RC70000, RC70072, RC70075, RC70077, RC70012BTT · Traditional | Smiths Medical Asd, Inc. | 10/20/2010SE |
| K100554 | Respiratory Humidifier , Heated Delivery System, Adaptor, Models MR880, RT241, 900MR441BTT · Traditional | Fisher & Paykel Healthcare, Ltd. | 05/28/2010SE |
| K092846 | Airvo Series HumidifiersBTT · Traditional | Fisher & Paykel Healthcare, Ltd. | 01/27/2010SE |
| K090915 | Sterile Water for Inhalation Flex Bag, UspBTT · Traditional | Cardinal Health, Inc. | 11/18/2009SE |
| K080149 | Heater Base, Model PMH7000BTT · Traditional | Pacific Medico Co., Ltd. | 12/18/2008SE |
| K072845 | Precision FlowBTT · Traditional | Vapotherm, Inc. | 07/17/2008SE |
| K080797 | Humidaire 2IBTT · Traditional | Resmed, Ltd. | 07/09/2008SE |
| K073706 | Respiratory Humidifier, Model MR850BTT · Traditional | Fisher & Paykel Healthcare, Ltd. | 03/31/2008SE |
| K072982 | Pari Hydrate VBTT · Traditional | Pari Innovative Manufacturers, Inc. | 11/29/2007SE |
| K071958 | Thera-Heat Heated Humidifier and Adult Dual and Single Limb Heated Wire Ventilator…BTT · Traditional | Smiths Medical Asd, Inc. | 11/21/2007SE |
| K070714 | Medisize Gold Heater and BoosterBTT · Traditional | Medisize BV | 04/30/2007SE |
| K063758 | Choncha Therm Neptune Heated Humifier, Choncha Therm Neptune Heated Humifier…BTT · Traditional | Teleflex Medical | 04/23/2007SE |
| K070056 | Vapotherm Model# 2000I and 2000HBTT · Special | Vapotherm, Inc. | 04/13/2007SE |
| K070107 | Pari Hydrate GBTT · Traditional | Pari Innovative Manufacturers, Inc. | 02/23/2007SE |
| K062664 | Humidcare Heated Humidifier, Model 9S-004BTT · Traditional | Apex Medical Corp. | 12/06/2006SE |
| K061736 | Comfort Flo Humidification System and Nasal CannulaBTT · Traditional | Teleflex Medical | 08/18/2006SE |
| K062091 | Porous Media Humidiflow Humidifier for Universal HumidificationBTT · Traditional | Porous Media Corp. | 08/08/2006SE |
| K060790 | Breas, Model HA01BTT · Special | Breas Medical AB | 05/25/2006SE |
| K052615 | Medisize GoldBTT · Traditional | Medisize BV | 12/09/2005SE |
| K050990 | Remrest Heated HumidifierBTT · Traditional | Medical Industries America, Inc. | 05/02/2005SE |
| K050314 | AquinoxBTT · Traditional | Smiths Medical Asd, Inc. | 02/18/2005SE |
| K042184 | Goodknight H20, Model M-114600-00BTT · Traditional | Mallinckrodt Developpement France | 01/10/2005SE |
| K041963 | American Bantex Humidifier, Dry, Bubble, Models B9000, 3 Psi and B9100, 6 PsiBTT · Traditional | American Bantex Corp. | 10/20/2004SE |
| K042245 | Vapotherm MODEL#2000I, 200HBTT · Traditional | Vapotherm, Inc. | 08/30/2004SE |
| K020700 | PMH 5000 Heated Humidifier for Respiratory TherapyBTT · Traditional | Pegasus Research Corp. | 04/26/2004SE |
| K033710 | MR850 Respiratory Humidifier, Model MR850JHUBTT · Traditional | Fisher & Paykel Healthcare, Ltd. | 04/13/2004SE |
| K031176 | Invacare Polaris Ex Heated Humidifier, Model ISP4000BTT · Traditional | Invacare Corp. | 03/25/2004SE |
| K040507 | Taga Velocity Passover Humidifier with Heater, Model TM1000HBTT · Traditional | Taga Medical Technologies, Inc. | 03/04/2004SE |
| K031179 | Taga Velocity HumidifierBTT · Traditional | Taga Medical Technologies, Inc. | 07/17/2003SE |
| K031383 | Model 780BTT · Special | Hudson Respiratory Care, Inc. | 07/07/2003SE |
| K020332 | Respiratory Humidifier, Model MR850BTT · Traditional | Fisher & Paykel Healthcare, Ltd. | 07/07/2003SE |
| K013486 | Vapotherm 2000HBTT · Traditional | Vapotherm, Inc. | 05/30/2003SE |
| K013856 | PMH 1000 Heated HumidifierBTT · Traditional | Pegasus Research Corp. | 02/21/2003SE |
| K030090 | H2 Heated HumidifierBTT · Traditional | Respironics, Inc. | 01/24/2003SE |
| K020900 | Devilbiss Model 9200D Heated Humidifier SystemBTT · Traditional | Sunrise Medical Hhg, Inc. | 06/03/2002SE |
| K012633 | Respironics Heated HumidifierBTT · Traditional | Respironics, Inc. | 02/28/2002SE |
| K003973 | Respiratory Humidifier, Model HC150BTT · Traditional | Fisher & Paykel Healthcare, Ltd. | 06/01/2001SE |
| K003626 | Devilbiss HumidifierBTT · Traditional | Sunrise Medical Hhg, Inc. | 05/04/2001SE |
| K010578 | Taga Velocity Passover Humidifier Unit, Model MP1017BTT · Traditional | Taga Medical Technologies, Inc. | 04/25/2001SE |
| K003561 | Invacare Passover Humidifier Model ISP9700BTT · Traditional | Invacare Corp. | 04/17/2001SE |
| K010402 | Smooth-Flo CircuitBTT · Special | Hudson Respiratory Care, Inc. | 03/14/2001SE |
| K002454 | Breas HA50 Humidifier, Model HA50BTT · Abbreviated | Vital Signs, Inc. | 03/07/2001SE |
| K001213 | Conchatherm 2000 Humidification System, Models 500-00, -10, -20, -30, -40, -50, & -60BTT · Traditional | Hudson Respiratory Care, Inc. | 11/03/2000SE |
| K983783 | Heated HumidifierBTT · Traditional | Pegasus Research Corp. | 10/24/2000SE |
| K993282 | Ipi Humidifier ChamberBTT · Traditional | I.P.I. Medical Products | 09/18/2000SE |
| K993773 | Humid-HeatBTT · Traditional | Hudson Rcj AB | 09/13/2000SE |
| K000401 | Vapotherm, Model 2000IBTT · Traditional | Vapotherm, Inc. | 08/24/2000SE |
| K993355 | Hudson Rci Concha Column, Cat. No. 385-40 and Hudson Rci Circuit, Cat. No. 780-40…BTT · Traditional | Hudson Respiratory Care, Inc. | 05/24/2000SE |
| K990614 | Hme-BoosterBTT · Traditional | King Systems Corp. | 05/23/2000SE |
| K993268 | Mallinckrodt Dar Heated Wire Breathing CircuitBTT · Traditional | Mallinckrodt Dar S.R.L. | 04/19/2000SE |
| K983862 | Cloud 1 Humidification SystemBTT · Traditional | Respiratory Support Products, Inc. | 05/24/1999SE |
| K991484 | Airlife Bubble Humidifer, Model 002003 and 002006BTT · Special | Allegiance Healthcare Corp. | 05/13/1999SE |
| K983112 | Respiratory Humidifier, Model # MR850BTT · Traditional | Fisher & Paykel Healthcare, Ltd. | 11/10/1998SE |
| K971260 | Sullivan Humidaire Heated HumidifierBTT · Traditional | Resmed Corp | 09/04/1997SE |
| K970478 | SCT 3000 Heated HumidifierBTT · Traditional | Marquest Medical Products, Inc. | 07/16/1997SE |
| K964653 | Oasis HumidifierBTT · Traditional | Respironics, Inc. | 02/14/1997SE |
| K962223 | Water Chambers for ST 3000 Heated HumidifierBTT · Traditional | Marquest Medical Products, Inc. | 01/14/1997SE |
| K963025 | Sleepnet HUMIDIFIER,(84200 Packaged)BTT · Traditional | Sleepnet Corporation | 11/01/1996SE |
| K962079 | Humidifier AdapterBTT · Traditional | Automatic Liquid Packaging, Inc. | 07/31/1996SE |
| K953392 | HC500 Servo-Controlled Heated Respiratory Humidifier (& Accessories)BTT · Traditional | Fisher & Paykel Electronics , Ltd. | 03/12/1996SE |
| K945782 | HumidifierBTT · Traditional | Respironics, Inc. | 03/01/1996SE |
| K950582 | Sullivan Passover HumidiferBTT · Traditional | Rescare, Inc. | 09/15/1995SE |
| K923946 | Conchatherm IV Heated Molecular HumidifierBTT · Traditional | Hudson Respiratory Care, Inc. | 10/18/1994SE |
| K936000 | Puritan-Bennett Cascade I Series Humidifier ModificationBTT · Traditional | Puritan Bennett Corp. | 08/15/1994SE |
| K934140 | MR290 Humidification Chamber Single UseBTT · Traditional | Fisher & Paykel Electronics , Ltd. | 01/24/1994SE |
| K926161 | Res Q Air System Model HT-1000BTT · Traditional | C.F. Electronics, Inc. | 08/26/1993SE |
| K932570 | Mark I HumidifierBTT · Traditional | C.F. Electronics, Inc. | 08/25/1993SE |
| K915460 | Heated Respiratory Humidifier HC100BTT · Traditional | Fisher & Paykel Electronics , Ltd. | 01/15/1993SE |
| K923754 | Misty Ox Laminar Diffuser HumidifierBTT · Traditional | Medical Molding Corp. of America | 12/07/1992SE |
| K913367 | Models MR410 & MR480 Respiratory Humidifier/AccessBTT · Traditional | Fisher & Paykel Electronics , Ltd. | 06/25/1992SE |
| K915890 | Autoclavable Thera-Mist Humidifier P3600, ModifiedBTT · Traditional | Pegasus Research Corp. | 06/24/1992SE |
| K914686 | Thermo-Flow SetBTT · Traditional | Inhalation Plastics | 04/15/1992SE |
| K920306 | Opti-Mol Filtered Puncture PinBTT · Traditional | Automatic Liquid Packaging, Inc. | 04/06/1992SE |
| K913368 | Models MR700/MR720/MR730 Dual Servo Resp Humid AccBTT · Traditional | Fisher & Paykel Electronics , Ltd. | 01/13/1992SE |
| K911770 | Optimol Respiratory Humidification SystemBTT · Traditional | Automatic Liquid Packaging, Inc. | 10/15/1991SE |
| K903138 | Marquest SCT 3000, Heated Humidification SystemBTT · Traditional | Marquest Medical Products, Inc. | 10/11/1990SE |
| K902970 | Precision Medical Disposable HumidifierBTT · Traditional | Precision Medical, Inc. | 08/14/1990SE |
| K901762 | Prefilled Flexible R.T. Containers W/Ster. SodiumBTT · Traditional | Automatic Liquid Packaging, Inc. | 07/17/1990SE |
| K900854 | John Bunn: Medix Compact TravellerBTT · Traditional | The John Bunn Co. | 04/23/1990SE |
| K900602 | Devilbiss AP-50 Compressor/NebulizerBTT · Traditional | Devilbiss Health Care, Inc. | 04/23/1990SE |
| K900569 | Thermoprobe 210BTT · Traditional | Merced Medical, Inc. | 04/10/1990SE |
| K896315 | Bear VH820 Disposable Chamber AssemblyBTT · Traditional | Bear Medical Systems, Inc. | 01/22/1990SE |
| K892817 | Heated Respiratory HumidifierBTT · Traditional | Fisher & Paykel Electronics , Ltd. | 12/21/1989SE |
| K893122 | Heated Servo Humidifier, Model HDS 2BTT · Traditional | Lifetronics, Inc. | 10/20/1989SE |
| K894000 | Thera-Mist HumidifierBTT · Traditional | Pegasus Research Corp. | 08/28/1989SE |
| K893034 | VHS 820 Humidifier, ModificationBTT · Traditional | Bear Medical Systems, Inc. | 07/14/1989SE |
| K881970 | Model MR2000 Heated Respiratory HumidifierBTT · Traditional | Fisher & Paykel Healthcare, Ltd. | 03/09/1989SE |
| K885314 | HPD Sterile Humidifying ChamberBTT · Traditional | Hpd Medical, Inc. | 01/17/1989SE |
| K884150 | Modified Conchatherm III Controlled HeaterBTT · Traditional | Respiratory Care, Inc. | 11/21/1988SE |
| K882582 | Sterile Inhalation Water Transfer SetBTT · Traditional | Intertech Resources, Inc. | 09/30/1988SE |
| K880979 | Marquest SCT 2000, Heated Humidification SystemBTT · Traditional | Marquest Medical Products, Inc. | 07/15/1988SE |
| K880702 | Model MR430 Special Purpose Humid. Heater BasesBTT · Traditional | Fisher & Paykel Allied Products , Ltd. | 07/08/1988SE |
| K881184 | Intertech Sterile Water for InhalationBTT · Traditional | Delmed, Inc. | 05/25/1988SE |
| K874659 | Sterilization of Devices by RadiationBTT · Traditional | Inhalation Plastics | 02/02/1988SE |
| K873472 | Membrane HumidifierBTT · Traditional | Respiratory Support Products, Inc. | 01/19/1988SE |
| K873634 | Bear VH-820 HumidifierBTT · Traditional | Bear Medical Systems, Inc. | 12/02/1987SE |
| K872138 | MR630 Enhanced Dual Servo Heater HumidifierBTT · Traditional | Fisher & Paykel Allied Products , Ltd. | 10/07/1987SE |
| K872139 | MR420 Transport HumidifierBTT · Traditional | Fisher & Paykel Allied Products , Ltd. | 09/15/1987SE |
| K871618 | Prefilled Sterile Water for Inhalation, UspBTT · Traditional | Automatic Liquid Packaging, Inc. | 05/08/1987SE |
| K870173 | Lavabed System & Chamber, Lavapak Temp. ControlBTT · Traditional | Mauna Loa Medical, Inc. | 04/03/1987SE |
| K863377 | MR338 Servo Heated Delivery HumidifierBTT · Traditional | Fisher & Paykel Allied Products , Ltd. | 02/20/1987SE |
| K870055 | MR590 Dual Hose Heater Power PackBTT · Traditional | Fisher & Paykel Allied Products , Ltd. | 02/10/1987SE |
| K864173 | HPD Humidifying ChamberBTT · Traditional | Hpd Medical, Inc. | 01/30/1987SE |
| K863154 | Heated Jet Humidifier Model AMS-1020BTT · Traditional | Acutronic Medical Systems AG | 01/12/1987SE |
| K863955 | Colby Level AlarmBTT · Traditional | Respiratory Care, Inc. | 11/07/1986SE |
| K862923 | MR620 Dual Servo Heated Anaesthesia HumidifierBTT · Traditional | Fisher & Paykel Allied Products , Ltd. | 09/23/1986SE |
| K854363 | Saratoga SCT Heated Humidification SystemBTT · Traditional | Saratoga Medical Instrumentation, Inc. | 12/31/1985SE |
| K851879 | Heated Respiratory HumidifierBTT · Traditional | Fisher & Paykel Allied Products , Ltd. | 09/03/1985SE |
| K853146 | Respir Ther Humid Contain Sterile Water for UspBTT · Traditional | Automatic Liquid Packaging, Inc. | 08/06/1985SE |
| K851940 | Sterile Water for Inhalation Usp 2D0799BTT · Traditional | Travenol Laboratories, S.A. | 06/20/1985SE |
| K850647 | Heated Respiratory Humififier MR440BTT · Traditional | Fisher & Paykel Allied Products , Ltd. | 03/12/1985SE |
| K843903 | Heated Respiratory Humidifier MR428BTT · Traditional | Fisher & Paykel Allied Products , Ltd. | 10/22/1984SE |
| K843932 | Vapor-Phase Humidifier Sys-AdvancedBTT · Traditional | Inspiron Corp. | 10/18/1984SE |
| K842795 | Maxi-Miser Humidifier Insert 1030BTT · Traditional | Nova-Ventrx | 10/04/1984SE |
| K842794 | Maxi-Miser Humidifier Insert 1020 & 1021BTT · Traditional | Nova-Ventrx | 10/04/1984SE |
| K841295 | Hypothermia Oxygen Warmer-Treatment SysBTT · Traditional | Bow/Parm | 08/08/1984SE |
| K842340 | VH820 HumidifierBTT · Traditional | Bear Medical Systems, Inc. | 07/17/1984SE |
| K842523 | Bird Heated Humidifier 3201BTT · Traditional | 3M Company | 07/11/1984SE |
| K841851 | HPD Humidifier WickBTT · Traditional | Hpd Medical, Inc. | 06/05/1984SE |
| K841158 | Nebulo 28 Nebulizer KitBTT · Traditional | Inspiron Corp. | 03/30/1984SE |
| K834151 | Conchatherm LHF Humidifier HeaterBTT · Traditional | Respiratory Care, Inc. | 01/13/1984SE |
| K833974 | Aquapak 020 Humidifier AdapterBTT · Traditional | Respiratory Care, Inc. | 12/16/1983SE |
| K832928 | Servo Heated Respiratory HumidifierBTT · Traditional | Fisher & Paykel Allied Products , Ltd. | 11/25/1983SE |
| K831556 | Vapor-Phase Humidifier SystemBTT · Traditional | Cygnus Research Corp. | 07/19/1983SE |
| K830913 | Minitrop Aerosal, Prodomo Aerosal andBTT · Traditional | Medlog GmbH Marketing Services | 05/25/1983SE |
| K831163 | Lo-Comp RESERVOIR-RE-1000BTT · Traditional | Cygnus Research Corp. | 05/03/1983SE |
| K823143 | Bubble HumidifiersBTT · Traditional | Seven Harvest Intl. Import & Export | 11/29/1982SE |
| K822816 | Dual Servo Heated Respiratory HumidifierBTT · Traditional | Fisher & Paykel Allied Products , Ltd. | 10/22/1982SE |
| K820878 | Concho Pediatric PackBTT · Traditional | Rci, Inc. | 05/03/1982SE |
| K812957 | East Autoclave HumidifierBTT · Traditional | Cairco , Ltd. | 03/12/1982SE |
| K811073 | A QuapakBTT · Traditional | Respiratory Care, Inc. | 04/29/1981SE |
| K810939 | Nebulizer/Humidifier Humidity Center-Mi.BTT · Traditional | Allied Healthcare Products, Inc. | 04/23/1981SE |
| K810559 | Opti- SystemBTT · Traditional | Corpak Co. | 03/17/1981SE |
| K810219 | Prefilled HumidiferBTT · Traditional | Corpak Co. | 03/04/1981SE |
| K802852 | HumidifierBTT · Traditional | Airlife, Inc. | 02/26/1981SE |
| K802145 | 2C 7140 Heated Humidifer CannisterBTT · Traditional | Travenol Laboratories, S.A. | 09/26/1980SE |
| K802144 | 2M8101 Heated Liquid Level ControllerBTT · Traditional | Travenol Laboratories, S.A. | 09/26/1980SE |
| K801619 | MIST2GEN Temptrol 10BTT · Traditional | Mistogen Equipment Co. | 08/04/1980SE |
| K801252 | Nebulizer with Air Entertainer & Etc.BTT · Traditional | Airlife, Inc. | 06/04/1980SE |
| K800753 | Sterile Water & Saline in Plastic Btl.BTT · Traditional | Travenol Laboratories, S.A. | 04/24/1980SE |
| K800056 | Ventilator SetBTT · Traditional | Abbott Laboratories | 01/24/1980SE |
| K792620 | Neonatal Heated HumidifierBTT · Traditional | Modern Medical Systems Co. | 01/24/1980SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2991-2026 Class II | Medline Hudson RCI, DBD-CIRCUIT,VENT,INSPIRATORY,HEATED,NEO, Medline Product Number/SKU…Neonatal and infant heated wire breathing circuits may experience sporadic failure. The heated wire… | Medline Industries, LP | 07/13/2026Open, Classified |
| Z-0158-2026 Class II | Airvo 2, REF: PT101US, and myAirvo 2, REF: PT100US, used with Disinfection Kit User…When unintentionally disconnected from power source, humidifier device (used to deliver high flow warmed and… | Fisher & Paykel Healthcare, Ltd. | 09/18/2025Open, Classified |
| Z-1823-2024 Class II | Airvo 2 Humidifier, REF: PT101US, and myAirvo 2 Humidifier, REF: PT100USHumidifier devices, used to deliver high flow respiratory therapy to patients, manufactured before 14 August… | Fisher & Paykel Healthcare, Ltd. | 04/02/2024Open, Classified |
| Z-1272-2023 Class II | Low Flow Disposable Patient Circuit for the Precision Flow System, Product Code PF-DPC-LOWThere have been reports of excessive condensation associated with certain lots of the Low Flow Disposable… | Vapotherm | 12/16/2022Open, Classified |
| Z-1385-2022 Class III | HAMILTON-H900 Humidifier, Models: 950001, 950004When starting a humidifier, intended for respiratory gas conditioning during invasive and noninvasive… | Hamilton Medical AG | 01/05/2021Completed |
| Z-1115-2020 Class I | HUDSON RCI COMFORT FLO Humidification System With Remote Temperature Port, REF 2414…There is the potential for water to flood the column and enter the circuit under circumstances where an… | Teleflex Medical Inc | 12/13/2019Terminated |
| Z-1114-2020 Class I | HUDSON RCI COMFORT FLO Humidification System, REF 2410, humidifier nebulizer kitThere is the potential for water to flood the column and enter the circuit under circumstances where an… | Teleflex Medical Inc | 12/13/2019Terminated |
| Z-1113-2020 Class I | HUDSON RCI COMFORT FLO Corrugated Humidification System with Remote Temperature Port…There is the potential for water to flood the column and enter the circuit under circumstances where an… | Teleflex Medical Inc | 12/13/2019Terminated |
| Z-1112-2020 Class I | HUDSON RCI COMFORT FLO Corrugated Humidification System, REF 2415, humidifier nebulizer…There is the potential for water to flood the column and enter the circuit under circumstances where an… | Teleflex Medical Inc | 12/13/2019Terminated |
| Z-1558-2015 Class II | Teleflex Medical Hudson RCI ConchaTherm Neptune Heated Humidifier, Rx Only.Customer complaints were received of power to the unit ceasing and the display going blank. | Teleflex Medical | 04/01/2015Terminated |
| Z-1109-2015 Class II | AQUAPAK 640 SW, 650ML W/040 ADAPTOR, INTL. Product Usage: The Humidifier Adaptor is an…The packages may contain foreign material (black particles). | Teleflex Medical | 01/14/2015Terminated |
| Z-1108-2015 Class II | AQUAPAK 340 SW, 340ML W/040 ADAPTOR, INTL. Product Usage: The Humidifier Adaptor is an…The packages may contain foreign material (black particles). | Teleflex Medical | 01/14/2015Terminated |
| Z-1107-2015 Class II | ADAPTOR, 040 HUM, INTL. Product Usage: The Humidifier Adaptor is an accessory which…The packages may contain foreign material (black particles). | Teleflex Medical | 01/14/2015Terminated |
| Z-1106-2015 Class II | AQUAPAK 640 SW, 650ML W/040 ADAPTOR, FREN. Product Usage: The Humidifier Adaptor is an…The packages may contain foreign material (black particles). | Teleflex Medical | 01/14/2015Terminated |
| Z-1105-2015 Class II | AQUAPAK 640 SW, 650ML W/040 ADAPTOR, FREN. Product Usage: The Humidifier Adaptor is an…The packages may contain foreign material (black particles). | Teleflex Medical | 01/14/2015Terminated |
| Z-1104-2015 Class II | AQUAPAK SW/EAU STERILE, 650 ML W/ADAPTOR. Product Usage: The Humidifier Adaptor is an…The packages may contain foreign material (black particles). | Teleflex Medical | 01/14/2015Terminated |
| Z-1103-2015 Class II | AQUAPAK 640 SW, 650ML W/040 ADAPTOR. Product Usage: The Humidifier Adaptor is an…The packages may contain foreign material (black particles). | Teleflex Medical | 01/14/2015Terminated |
| Z-1102-2015 Class II | AQUA 540 SW, 540 W/040 ADAPTOR. Product Usage: The Humidifier Adaptor is an accessory…The packages may contain foreign material (black particles). | Teleflex Medical | 01/14/2015Terminated |
| Z-1101-2015 Class II | AQUAPAK 340 SW, 340, ML W/040, ADAPTOR, JAPA. Product Usage: The Humidifier Adaptor is…The packages may contain foreign material (black particles). | Teleflex Medical | 01/14/2015Terminated |
| Z-1100-2015 Class II | AQUAPAK 340 SW, 340 ML W/040 ADAPTOR, FREN. Product Usage: The Humidifier Adaptor is an…The packages may contain foreign material (black particles). | Teleflex Medical | 01/14/2015Terminated |
| Z-1099-2015 Class II | AQUAPAK SW/EAU STERILE, 340 ML W/ADAPTOR Product Usage: The Humidifier Adaptor is an…The packages may contain foreign material (black particles). | Teleflex Medical | 01/14/2015Terminated |
| Z-1098-2015 Class II | AQUAPAK 340 SW, 340 ML W/040B ADAPTOR, BRI Product Usage: The Humidifier Adaptor is an…The packages may contain foreign material (black particles). | Teleflex Medical | 01/14/2015Terminated |
| Z-1097-2015 Class II | AQUAPAK 340 SW, 340 ML W/404 ADAPTOR. Product Usage: The Humidifier Adaptor is an…The packages may contain foreign material (black particles). | Teleflex Medical | 01/14/2015Terminated |
| Z-1096-2015 Class II | AQUAPAK 101 SW, 190ML W/040 ADAPTOR, JAPA Product Usage: The Humidifier Adaptor is an…The packages may contain foreign material (black particles). | Teleflex Medical | 01/14/2015Terminated |
| Z-1095-2015 Class II | Hudson RCI Humidifier Adaptor, 040 contained in the following units: HUMIDIFIER ADAPTOR…The packages may contain foreign material (black particles). | Teleflex Medical | 01/14/2015Terminated |
| Z-0346-2018 Class I | Adult AirLife dual-limb, dual-heat circuit (Model AH280) with AirLife Humidification…Manufacturing error in humidification chamber may cause an overfill/overflow condition of the chamber. The… | Vyaire Medical | 11/29/2014Terminated |
| Z-0345-2018 Class I | Adult Air-Life single-limb circuit (Model AH202) with AirLife Humidification Chamber…Manufacturing error in humidification chamber may cause an overfill/overflow condition of the chamber. The… | Vyaire Medical | 11/29/2014Terminated |
| Z-0344-2018 Class I | Infant AirLife Dual-,limb, dual-heat, high-flow circuit (Model AH265) with AirLife…Manufacturing error in humidification chamber may cause an overfill/overflow condition of the chamber. The… | Vyaire Medical | 11/29/2014Terminated |
| Z-0343-2018 Class I | Infant AirLife single-limb, continuous-flow circuit (Model AH132) containing AirLife…Manufacturing error in humidification chamber may cause an overfill/overflow condition of the chamber. The… | Vyaire Medical | 11/29/2014Terminated |
| Z-2706-2014 Class II | Vapotherm Precision Flow,Disposable Patient Circuit PF-NODPC-Low. For use with the…Water may leak into the center gas lumen of the Patient Circuit | Vapotherm, Inc. | 08/13/2014Terminated |
| Z-2705-2014 Class II | Vapotherm Precision Flow,Disposable Patient Circuit PFHDPC-Low. For use with the Heliox…Disposable Patient Circuit that allows water to leak into the center gas lumen | Vapotherm, Inc. | 08/13/2014Terminated |
| Z-2704-2014 Class II | Vapotherm Precision Flow,Disposable Patient Circuit PF-E-DPC-Low. PF-DPC-Low packaged…Disposable Patient Circuit that allows water to leak into the center gas lumen | Vapotherm, Inc. | 08/13/2014Terminated |
| Z-2703-2014 Class II | Vapotherm Precision Flow,Disposable Patient Circuit PF-DPC-Low. For use with the…Disposable Patient Circuit that allows water to leak into the center gas lumen | Vapotherm, Inc. | 08/13/2014Terminated |
| Z-2702-2014 Class II | Vapotherm Precision Flow,Disposable Patient Circuit PFNODPC-High. For use with the…Disposable Patient Circuit that allows water to leak into the center gas lumen | Vapotherm, Inc. | 08/13/2014Terminated |
| Z-2701-2014 Class II | Vapotherm Precision Flow,Disposable Patient Circuit PFH-DPC-High. For use with the…Disposable Patient Circuit that allows water to leak into the center gas lumen | Vapotherm, Inc. | 08/13/2014Terminated |
| Z-2700-2014 Class II | Vapotherm Precision Flow,Disposable Patient Circuit PF-E-DPC-High. For use with the…Disposable Patient Circuit that allows water to leak into the center gas lumen | Vapotherm, Inc. | 08/13/2014Terminated |
| Z-2699-2014 Class II | Vapotherm Precision Flow, Disposable Patient Circuit PF-DPC-High. For use with the…Disposable Patient Circuit that allows water to leak into the center gas lumen | Vapotherm, Inc. | 08/13/2014Terminated |
| Z-2107-2014 Class II | Hudson RCI, Breathing Circuit, Adult, Single Limb w/Heated Wire, [Respiratory Gas…The temperature probe does not properly connect to the temperature port. | Teleflex Medical | 07/09/2014Terminated |
| Z-2017-2014 Class II | Humidifier Adaptor, 040 Shelf Pak, French, Teleflex Medical, respiratory gas humidifier…The seals of the adaptor packaging may be creased which may potentially affect packaging integrity. | Teleflex Medical | 06/05/2014Terminated |
| Z-2016-2014 Class II | Humidifier Adaptor 040, Teleflex Medical, respiratory gas humidifier adaptor.The seals of the adaptor packaging may be creased which may potentially affect packaging integrity. | Teleflex Medical | 06/05/2014Terminated |
| Z-2015-2014 Class II | Adaptor, 040 Hum, International, Teleflex Medical, respiratory gas humidifier adaptor.The seals of the adaptor packaging may be creased which may potentially affect packaging integrity. | Teleflex Medical | 06/05/2014Terminated |
| Z-2014-2014 Class II | Aquapak 640 SW, 650 mL w/040 Adaptor, Japan, Teleflex Medical, respiratory gas…The seals of the adaptor packaging may be creased which may potentially affect packaging integrity. | Teleflex Medical | 06/05/2014Terminated |
| Z-2013-2014 Class II | Aquapak 640 SW, 650 mL w/040 Adaptor, French, Teleflex Medical, respiratory gas…The seals of the adaptor packaging may be creased which may potentially affect packaging integrity. | Teleflex Medical | 06/05/2014Terminated |
| Z-2012-2014 Class II | Aquapak 640 SW, 650 mL w/040 Adaptor, Teleflex Medical, respiratory gas humidifier…The seals of the adaptor packaging may be creased which may potentially affect packaging integrity. | Teleflex Medical | 06/05/2014Terminated |
| Z-2011-2014 Class II | Aquapak SW/EAU Sterile, 650 mL w/Adaptor, Teleflex Medical, respiratory gas humidifier…The seals of the adaptor packaging may be creased which may potentially affect packaging integrity. | Teleflex Medical | 06/05/2014Terminated |
| Z-2010-2014 Class II | Aqua 540 SW, 540 w/040 Adaptor, Teleflex Medical, respiratory gas humidifier adaptor.The seals of the adaptor packaging may be creased which may potentially affect packaging integrity. | Teleflex Medical | 06/05/2014Terminated |
| Z-2009-2014 Class II | Aquapak 340 SW, 340, mL w/040 Adaptor, Japan, Teleflex Medical, respiratory gas…The seals of the adaptor packaging may be creased which may potentially affect packaging integrity. | Teleflex Medical | 06/05/2014Terminated |
| Z-2008-2014 Class II | Aquapak 340 SW, 340, mL w/040 Adaptor, French, Teleflex Medical, respiratory gas…The seals of the adaptor packaging may be creased which may potentially affect packaging integrity. | Teleflex Medical | 06/05/2014Terminated |
| Z-2007-2014 Class II | Aquapak SW/EAU, Sterile, 340 mL, w/Adaptor, Teleflex Medical, respiratory gas humidifier…The seals of the adaptor packaging may be creased which may potentially affect packaging integrity. | Teleflex Medical | 06/05/2014Terminated |
| Z-2006-2014 Class II | Aquapak 340 SW, 340, mL w/040 Adaptor, Teleflex Medical, respiratory gas humidifier…The seals of the adaptor packaging may be creased which may potentially affect packaging integrity. | Teleflex Medical | 06/05/2014Terminated |