Product Code: BTT FDA class 2 21 CFR 868.5450

Humidifier, Respiratory Gas, (Direct Patient Interface)

Anesthesiology

The Humidifier, Respiratory Gas (Direct Patient Interface) is a device that adds moisture to respiratory gases delivered directly to a patient's airway during mechanical ventilation or anesthesia, helping to prevent drying of the mucous membranes. It is classified as FDA Class 2, requiring 510(k) premarket notification. The product code is BTT, regulated under 21 CFR 868.5450 in the Anesthesiology specialty.

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510(k)s

221

FEI Numbers

108

Registration Numbers

108

Unique Applicants

Years Active

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Basic Information

Product Code: BTT
Device Class: FDA class 2
Regulation Number: 868.5450
Medical Specialty: Anesthesiology
Review Panel: AN
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 221 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K254078	HVT 2.0	Apr 13, 2026	Substantially Equivalent	Vapotherm, Inc.
K251448	FL-10000U Respiratory Humidifier	Jan 16, 2026	Substantially Equivalent	Flexicare Medical Limited.
K251419	Laboratorios Biogalenic Sterile Water for Inhalation, USP	Jan 14, 2026	Substantially Equivalent	Laboratorios Biogalenic S.A. DE C.V.
K253479	Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J)	Dec 19, 2025	Substantially Equivalent	Fisher & Paykel Healthcare, Ltd.
K250312	Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus and Soft Plus Cannula Extra Small	Jul 02, 2025	Substantially Equivalent	Medline Industries, LP
K251611	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)	Jun 25, 2025	Substantially Equivalent	Fisher & Paykel Healthcare, Ltd.
K242717	Laboratorios Biogalenic Sterile Water for Inhalation, USP	Jan 30, 2025	Substantially Equivalent	Laboratorios Biogalenic S.A. DE C.V.
K241778	Hudson RCI Comfort Flo® CubCannula	Dec 19, 2024	Substantially Equivalent	Medline Industries, LP
K240163	Hudson RCI® Comfort Flo Nasal Cannula; Hudson RCI® Comfort Flo Plus Cannula	Sep 27, 2024	Substantially Equivalent	Medline Industries, LP
K234058	F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility (AA041J)	Aug 08, 2024	Substantially Equivalent	Fisher & Paykel Healthcare, Ltd.
K233707	HFT150	Jun 14, 2024	Substantially Equivalent	Invent Medical Corporation
K233821	F&P Optiflow Oxygen Kit (AA451J)	Jun 13, 2024	Substantially Equivalent	Fisher & Paykel Healthcare, Ltd.
K222292	F&P myAirvo 3	May 08, 2024	Substantially Equivalent	Fisher & Paykel Healthcare
K231956	F&P Optiflow+ Duet Nasal Cannula	Feb 07, 2024	Substantially Equivalent	Fisher & Paykel Healthcare, Ltd.
K230559	Hudson RCI® Disposable Humidifier with 4 PSI Pressure Relief Valve (3230), Hudson RCI® Disposable Humidifier with 6 PSI Pressure Relief Valve (3260)	Oct 26, 2023	Substantially Equivalent	Medline Industries, Inc.
K223863	BONHAWA Respiratory Humidifier	Oct 13, 2023	Substantially Equivalent	Telesair, Inc.
K223684	F&P 820 Humidification System	Sep 05, 2023	Substantially Equivalent	Fisher & Paykel Healthcare, Ltd.
K231380	AirLife DuoTherm Humidification System	Aug 10, 2023	Substantially Equivalent	Vyaire Medical, Inc.
K223551	Sterile Water for Inhalation in 1L Flexoval ® bottles.	Aug 03, 2023	Substantially Equivalent	Hometa, Inc.
K220703	F&P 950 Respiratory Humidifier	Jun 16, 2023	Substantially Equivalent	Fisher & Paykel Healthcare
K222197	F&P Optiflow Junior 2/2+ Nasal Cannula Interface Range	Apr 06, 2023	Substantially Equivalent	Fisher & Paykel Healthcare, Ltd.
K222351	inspired VHB20 Heated Humidifier	Dec 21, 2022	Substantially Equivalent	Vincent Healthcare Products Limited
K212031	F&P 850 AirSpiral Adult NIV and NHF Circuit Kit	Apr 22, 2022	Substantially Equivalent	Fisher & Paykel Healthcare, Ltd.
K211096	Optiflow Oxygen Kit	Jan 28, 2022	Substantially Equivalent	Fisher & Paykel Healthcare, Ltd.
K203357	HVT 2.0	Aug 25, 2021	Substantially Equivalent	Vapotherm, Inc.
K201723	F&P Optiflow Nasal Oxygen Cannula with CO2 Sampling	Mar 16, 2021	Substantially Equivalent	Fisher & Paykel Healthcare, Ltd.
K193411	O2asis Personal Oxygen Humidifier	Nov 12, 2020	Substantially Equivalent	Perma Pure, LLC
K191818	F&P Optiflow 3S Nasal Cannula (Small, Medium, Large)	Mar 19, 2020	Substantially Equivalent	Fisher & Paykel Healthcare, Ltd.
K191010	Palladium High Flow Therapy System	Oct 10, 2019	Substantially Equivalent	Vapotherm, Inc.
K162553	AirSpiral Heated Breathing Tube	Dec 20, 2018	Substantially Equivalent	Fisher & Paykel Healthcare
K180474	TNI softFlow 50	Oct 18, 2018	Substantially Equivalent	Tni Medical AG
K161719	Salter Labs Bubble Humidifier	Sep 21, 2017	Substantially Equivalent	Salter Labs
K163283	HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010	Sep 20, 2017	Substantially Equivalent	Hamilton Medical AG
K162242	Comfort Flo Humidification System	Jan 19, 2017	Substantially Equivalent	Teleflexmedical, Inc.
K160764	AirLife Autofill Humidification Chamber	Aug 25, 2016	Substantially Equivalent	Carefusion 2200, Inc.
K161314	FLEXICARE FL-9000U RESPIRATORY HUMIDIFIER BASE	Jul 06, 2016	Substantially Equivalent	Flexicare Medical Limited.
K152029	HAMILTON-H900, HAMILTON-BC8022, HAMILTON-BC4022, HAMILTON-BC8010, HAMILTON-BC4010	May 03, 2016	Substantially Equivalent	Hamilton Medical AG
K143646	MR810 System, 900MR810 Adult Single Limb Circuit, 900MR810E Adult Dual Limb Circuit	Mar 05, 2015	Substantially Equivalent	Fisher & Paykel Healthcare, Ltd.
K141940	CONCHASMART COLUMN	Nov 24, 2014	Substantially Equivalent	Teleflex, Inc.
K133766	HUMICARE D900	Nov 24, 2014	Substantially Equivalent	Gruendler GmbH
K140556	CONCHASMART BREATHING CIRCUIT	Sep 24, 2014	Substantially Equivalent	Teleflex, Inc.
K141353	HUDSON RCI AQUAPAK HUMIDIFIER ADAPTOR	Aug 01, 2014	Substantially Equivalent	Teleflexmedical, Inc.
K132857	RESPIRATORY GAS HUMIDIFIER	May 01, 2014	Substantially Equivalent	Pacific Medico Co., Ltd.
K132017	HC550 RESPIRATORY HUMIDIFIER, ADULT VENTILATOR CIRCUIT	Mar 25, 2014	Substantially Equivalent	Fisher & Paykel Healthcare, Ltd.
K131912	CONCHATHERM NEPTUNE HEATED HUMIDIFIER, COMFORT FLO HUMIDIFICATION SYSTEM, CONCHASMART COLUMN	Mar 06, 2014	Substantially Equivalent	Teleflex, Inc.
K131957	MR810RESPIRATORY HUMIDIFIER, 900MR810 ADULT SINGLE LIMB CIRCUIT, 900MR810E ADULT DUAL LIMB CIRCUIT	Dec 04, 2013	Substantially Equivalent	Fisher & Paykel Healthcare, Ltd.
K131895	AIRVO 2 HUMIDIFIER, MYAIRVO 2 HUMIDIFIER	Oct 24, 2013	Substantially Equivalent	Fisher & Paykel Healthcare, Ltd.
K131388	TRANSCEND HEATED HUMIDIFIER	Sep 26, 2013	Substantially Equivalent	Somnetics International, Inc.
K122885	MEDISIZE GOLD HEATER AND BOOSTER T-PIECE	Aug 29, 2013	Substantially Equivalent	Medisize BV
K122705	HUMICARE D900	May 21, 2013	Substantially Equivalent	Grundler GmbH
K121975	AIRVO HUMIDIFIER MYAIRO HUMIDIFIER	Jan 03, 2013	Substantially Equivalent	Fisher & Paykel Healthcare, Ltd.
K110019	RESPIRATORY HUMIDIFER	Mar 30, 2012	Substantially Equivalent	Fisher & Paykel Healthcare, Ltd.
K113542	SALTER LABS BUBBLE HUMIDIFIER (HIGH FLOW)	Feb 10, 2012	Substantially Equivalent	Salter Labs, Arvin Facility
K111640	PRECISION FLOW(R) - HELIOX	Oct 07, 2011	Substantially Equivalent	Vapotherm, Inc.
K103316	FLOWREST	Feb 08, 2011	Substantially Equivalent	Vapotherm, Inc.
K093617	VENTLAB 6000 SERIES HUMIDIFIER	Jan 27, 2011	Substantially Equivalent	Ventlab Corp.
K102618	VENTSTAR HEATED, INFINITY ID BREATHING CIRCUIT HEATED	Dec 10, 2010	Substantially Equivalent	Draeger Medical AG & Co. KG
K092256	THERA- HEAT HEATED HUMIDIFIER, MODEL RC70000, RC70072, RC70075, RC70077, RC70012	Oct 20, 2010	Substantially Equivalent	Smiths Medical Asd, Inc.
K100554	RESPIRATORY HUMIDIFIER , HEATED DELIVERY SYSTEM, ADAPTOR, MODELS MR880, RT241, 900MR441	May 28, 2010	Substantially Equivalent	Fisher & Paykel Healthcare, Ltd.
K092846	AIRVO SERIES HUMIDIFIERS	Jan 27, 2010	Substantially Equivalent	Fisher & Paykel Healthcare, Ltd.
K090915	STERILE WATER FOR INHALATION FLEX BAG, USP	Nov 18, 2009	Substantially Equivalent	Cardinal Health, Inc.
K080149	HEATER BASE, MODEL PMH7000	Dec 18, 2008	Substantially Equivalent	Pacific Medico Co., Ltd.
K072845	PRECISION FLOW	Jul 17, 2008	Substantially Equivalent	Vapotherm, Inc.
K080797	HUMIDAIRE 2I	Jul 09, 2008	Substantially Equivalent	Resmed, Ltd.
K073706	RESPIRATORY HUMIDIFIER, MODEL MR850	Mar 31, 2008	Substantially Equivalent	Fisher & Paykel Healthcare, Ltd.
K072982	PARI HYDRATE V	Nov 29, 2007	Substantially Equivalent	Pari Innovative Manufacturers, Inc.
K071958	THERA-HEAT HEATED HUMIDIFIER AND ADULT DUAL AND SINGLE LIMB HEATED WIRE VENTILATOR BREATHING CIRCUITS	Nov 21, 2007	Substantially Equivalent	Smiths Medical Asd, Inc.
K070714	MEDISIZE GOLD HEATER AND BOOSTER	Apr 30, 2007	Substantially Equivalent	Medisize BV
K063758	CHONCHA THERM NEPTUNE HEATED HUMIFIER, CHONCHA THERM NEPTUNE HEATED HUMIFIER (REMANUFACTURER), MODEL# 425-00,425-00R	Apr 23, 2007	Substantially Equivalent	Teleflex Medical
K070056	VAPOTHERM MODEL# 2000I AND 2000H	Apr 13, 2007	Substantially Equivalent	Vapotherm, Inc.
K070107	PARI HYDRATE G	Feb 23, 2007	Substantially Equivalent	Pari Innovative Manufacturers, Inc.
K062664	HUMIDCARE HEATED HUMIDIFIER, MODEL 9S-004	Dec 06, 2006	Substantially Equivalent	Apex Medical Corp.
K061736	COMFORT FLO HUMIDIFICATION SYSTEM AND NASAL CANNULA	Aug 18, 2006	Substantially Equivalent	Teleflex Medical
K062091	POROUS MEDIA HUMIDIFLOW HUMIDIFIER FOR UNIVERSAL HUMIDIFICATION	Aug 08, 2006	Substantially Equivalent	Porous Media Corp.
K060790	BREAS, MODEL HA01	May 25, 2006	Substantially Equivalent	Breas Medical AB
K052615	MEDISIZE GOLD	Dec 09, 2005	Substantially Equivalent	Medisize BV
K050990	REMREST HEATED HUMIDIFIER	May 02, 2005	Substantially Equivalent	Medical Industries America, Inc.
K050314	AQUINOX	Feb 18, 2005	Substantially Equivalent	Smiths Medical Asd, Inc.
K042184	GOODKNIGHT H20, MODEL M-114600-00	Jan 10, 2005	Substantially Equivalent	Mallinckrodt Developpement France
K041963	AMERICAN BANTEX HUMIDIFIER, DRY, BUBBLE, MODELS B9000, 3 PSI AND B9100, 6 PSI	Oct 20, 2004	Substantially Equivalent	American Bantex Corp.
K042245	VAPOTHERM MODEL#2000I, 200H	Aug 30, 2004	Substantially Equivalent	Vapotherm, Inc.
K020700	PMH 5000 HEATED HUMIDIFIER FOR RESPIRATORY THERAPY	Apr 26, 2004	Substantially Equivalent	Pegasus Research Corp.
K033710	MR850 RESPIRATORY HUMIDIFIER, MODEL MR850JHU	Apr 13, 2004	Substantially Equivalent	Fisher & Paykel Healthcare, Ltd.
K031176	INVACARE POLARIS EX HEATED HUMIDIFIER, MODEL ISP4000	Mar 25, 2004	Substantially Equivalent	Invacare Corp.
K040507	TAGA VELOCITY PASSOVER HUMIDIFIER WITH HEATER, MODEL TM1000H	Mar 04, 2004	Substantially Equivalent	Taga Medical Technologies, Inc.
K031179	TAGA VELOCITY HUMIDIFIER	Jul 17, 2003	Substantially Equivalent	Taga Medical Technologies, Inc.
K031383	MODEL 780	Jul 07, 2003	Substantially Equivalent	Hudson Respiratory Care, Inc.
K020332	RESPIRATORY HUMIDIFIER, MODEL MR850	Jul 07, 2003	Substantially Equivalent	Fisher & Paykel Healthcare, Ltd.
K013486	VAPOTHERM 2000H	May 30, 2003	Substantially Equivalent	Vapotherm, Inc.
K013856	PMH 1000 HEATED HUMIDIFIER	Feb 21, 2003	Substantially Equivalent	Pegasus Research Corp.
K030090	H2 HEATED HUMIDIFIER	Jan 24, 2003	Substantially Equivalent	Respironics, Inc.
K020900	DEVILBISS MODEL 9200D HEATED HUMIDIFIER SYSTEM	Jun 03, 2002	Substantially Equivalent	Sunrise Medical Hhg, Inc.
K012633	RESPIRONICS HEATED HUMIDIFIER	Feb 28, 2002	Substantially Equivalent	Respironics, Inc.
K003973	RESPIRATORY HUMIDIFIER, MODEL HC150	Jun 01, 2001	Substantially Equivalent	Fisher & Paykel Healthcare, Ltd.
K003626	DEVILBISS HUMIDIFIER	May 04, 2001	Substantially Equivalent	Sunrise Medical Hhg, Inc.
K010578	TAGA VELOCITY PASSOVER HUMIDIFIER UNIT, MODEL MP1017	Apr 25, 2001	Substantially Equivalent	Taga Medical Technologies, Inc.
K003561	INVACARE PASSOVER HUMIDIFIER MODEL ISP9700	Apr 17, 2001	Substantially Equivalent	Invacare Corp.
K010402	SMOOTH-FLO CIRCUIT	Mar 14, 2001	Substantially Equivalent	Hudson Respiratory Care, Inc.
K002454	BREAS HA50 HUMIDIFIER, MODEL HA50	Mar 07, 2001	Substantially Equivalent	Vital Signs, Inc.
K001213	CONCHATHERM 2000 HUMIDIFICATION SYSTEM, MODELS 500-00, -10, -20, -30, -40, -50, & -60	Nov 03, 2000	Substantially Equivalent	Hudson Respiratory Care, Inc.
K983783	HEATED HUMIDIFIER	Oct 24, 2000	Substantially Equivalent	Pegasus Research Corp.
K993282	IPI HUMIDIFIER CHAMBER	Sep 18, 2000	Substantially Equivalent	I.P.I. Medical Products
K993773	HUMID-HEAT	Sep 13, 2000	Substantially Equivalent	Hudson Rcj AB
K000401	VAPOTHERM, MODEL 2000I	Aug 24, 2000	Substantially Equivalent	Vapotherm, Inc.
K993355	HUDSON RCI CONCHA COLUMN, CAT. NO. 385-40 AND HUDSON RCI CIRCUIT, CAT. NO. 780-40, 780-41, 780-42, 780-43	May 24, 2000	Substantially Equivalent	Hudson Respiratory Care, Inc.
K990614	HME-BOOSTER	May 23, 2000	Substantially Equivalent	King Systems Corp.
K993268	MALLINCKRODT DAR HEATED WIRE BREATHING CIRCUIT	Apr 19, 2000	Substantially Equivalent	Mallinckrodt Dar S.R.L.
K983862	CLOUD 1 HUMIDIFICATION SYSTEM	May 24, 1999	Substantially Equivalent	Respiratory Support Products, Inc.
K991484	AIRLIFE BUBBLE HUMIDIFER, MODEL 002003 AND 002006	May 13, 1999	Substantially Equivalent	Allegiance Healthcare Corp.
K983112	RESPIRATORY HUMIDIFIER, MODEL # MR850	Nov 10, 1998	Substantially Equivalent	Fisher & Paykel Healthcare, Ltd.
K971260	SULLIVAN HUMIDAIRE HEATED HUMIDIFIER	Sep 04, 1997	Substantially Equivalent	Resmed Corp
K970478	SCT 3000 HEATED HUMIDIFIER	Jul 16, 1997	Substantially Equivalent	Marquest Medical Products, Inc.
K964653	OASIS HUMIDIFIER	Feb 14, 1997	Substantially Equivalent	Respironics, Inc.
K962223	WATER CHAMBERS FOR ST 3000 HEATED HUMIDIFIER	Jan 14, 1997	Substantially Equivalent	Marquest Medical Products, Inc.
K963025	SLEEPNET HUMIDIFIER,(84200 PACKAGED)	Nov 01, 1996	Substantially Equivalent	Sleepnet Corporation
K962079	HUMIDIFIER ADAPTER	Jul 31, 1996	Substantially Equivalent	Automatic Liquid Packaging, Inc.
K953392	HC500 SERVO-CONTROLLED HEATED RESPIRATORY HUMIDIFIER (& ACCESSORIES)	Mar 12, 1996	Substantially Equivalent	Fisher & Paykel Electronics , Ltd.
K945782	HUMIDIFIER	Mar 01, 1996	Substantially Equivalent	Respironics, Inc.
K950582	SULLIVAN PASSOVER HUMIDIFER	Sep 15, 1995	Substantially Equivalent	Rescare, Inc.
K923946	CONCHATHERM IV HEATED MOLECULAR HUMIDIFIER	Oct 18, 1994	Substantially Equivalent	Hudson Respiratory Care, Inc.
K936000	PURITAN-BENNETT CASCADE I SERIES HUMIDIFIER MODIFICATION	Aug 15, 1994	Substantially Equivalent	Puritan Bennett Corp.
K934140	MR290 HUMIDIFICATION CHAMBER SINGLE USE	Jan 24, 1994	Substantially Equivalent	Fisher & Paykel Electronics , Ltd.
K926161	RES Q AIR SYSTEM MODEL HT-1000	Aug 26, 1993	Substantially Equivalent	C.F. Electronics, Inc.
K932570	MARK I HUMIDIFIER	Aug 25, 1993	Substantially Equivalent	C.F. Electronics, Inc.
K915460	HEATED RESPIRATORY HUMIDIFIER HC100	Jan 15, 1993	Substantially Equivalent	Fisher & Paykel Electronics , Ltd.
K923754	MISTY OX LAMINAR DIFFUSER HUMIDIFIER	Dec 07, 1992	Substantially Equivalent	Medical Molding Corp. of America
K913367	MODELS MR410 & MR480 RESPIRATORY HUMIDIFIER/ACCESS	Jun 25, 1992	Substantially Equivalent	Fisher & Paykel Electronics , Ltd.
K915890	AUTOCLAVABLE THERA-MIST HUMIDIFIER P3600, MODIFIED	Jun 24, 1992	Substantially Equivalent	Pegasus Research Corp.
K914686	THERMO-FLOW SET	Apr 15, 1992	Substantially Equivalent	Inhalation Plastics
K920306	OPTI-MOL FILTERED PUNCTURE PIN	Apr 06, 1992	Substantially Equivalent	Automatic Liquid Packaging, Inc.
K913368	MODELS MR700/MR720/MR730 DUAL SERVO RESP HUMID ACC	Jan 13, 1992	Substantially Equivalent	Fisher & Paykel Electronics , Ltd.
K911770	OPTIMOL RESPIRATORY HUMIDIFICATION SYSTEM	Oct 15, 1991	Substantially Equivalent	Automatic Liquid Packaging, Inc.
K903138	MARQUEST SCT 3000, HEATED HUMIDIFICATION SYSTEM	Oct 11, 1990	Substantially Equivalent	Marquest Medical Products, Inc.
K902970	PRECISION MEDICAL DISPOSABLE HUMIDIFIER	Aug 14, 1990	Substantially Equivalent	Precision Medical, Inc.
K901762	PREFILLED FLEXIBLE R.T. CONTAINERS W/STER. SODIUM	Jul 17, 1990	Substantially Equivalent	Automatic Liquid Packaging, Inc.
K900854	JOHN BUNN: MEDIX COMPACT TRAVELLER	Apr 23, 1990	Substantially Equivalent	The John Bunn Co.
K900602	DEVILBISS AP-50 COMPRESSOR/NEBULIZER	Apr 23, 1990	Substantially Equivalent	Devilbiss Health Care, Inc.
K900569	THERMOPROBE 210	Apr 10, 1990	Substantially Equivalent	Merced Medical, Inc.
K896315	BEAR VH820 DISPOSABLE CHAMBER ASSEMBLY	Jan 22, 1990	Substantially Equivalent	Bear Medical Systems, Inc.
K892817	HEATED RESPIRATORY HUMIDIFIER	Dec 21, 1989	Substantially Equivalent	Fisher & Paykel Electronics , Ltd.
K893122	HEATED SERVO HUMIDIFIER, MODEL HDS 2	Oct 20, 1989	Substantially Equivalent	Lifetronics, Inc.
K894000	THERA-MIST HUMIDIFIER	Aug 28, 1989	Substantially Equivalent	Pegasus Research Corp.
K893034	VHS 820 HUMIDIFIER, MODIFICATION	Jul 14, 1989	Substantially Equivalent	Bear Medical Systems, Inc.
K881970	MODEL MR2000 HEATED RESPIRATORY HUMIDIFIER	Mar 09, 1989	Substantially Equivalent	Fisher & Paykel Healthcare, Ltd.
K885314	HPD STERILE HUMIDIFYING CHAMBER	Jan 17, 1989	Substantially Equivalent	Hpd Medical, Inc.
K884150	MODIFIED CONCHATHERM III CONTROLLED HEATER	Nov 21, 1988	Substantially Equivalent	Respiratory Care, Inc.
K882582	STERILE INHALATION WATER TRANSFER SET	Sep 30, 1988	Substantially Equivalent	Intertech Resources, Inc.
K880979	MARQUEST SCT 2000, HEATED HUMIDIFICATION SYSTEM	Jul 15, 1988	Substantially Equivalent	Marquest Medical Products, Inc.
K880702	MODEL MR430 SPECIAL PURPOSE HUMID. HEATER BASES	Jul 08, 1988	Substantially Equivalent	Fisher & Paykel Allied Products , Ltd.
K881184	INTERTECH STERILE WATER FOR INHALATION	May 25, 1988	Substantially Equivalent	Delmed, Inc.
K874659	STERILIZATION OF DEVICES BY RADIATION	Feb 02, 1988	Substantially Equivalent	Inhalation Plastics
K873472	MEMBRANE HUMIDIFIER	Jan 19, 1988	Substantially Equivalent	Respiratory Support Products, Inc.
K873634	BEAR VH-820 HUMIDIFIER	Dec 02, 1987	Substantially Equivalent	Bear Medical Systems, Inc.
K872138	MR630 ENHANCED DUAL SERVO HEATER HUMIDIFIER	Oct 07, 1987	Substantially Equivalent	Fisher & Paykel Allied Products , Ltd.
K872139	MR420 TRANSPORT HUMIDIFIER	Sep 15, 1987	Substantially Equivalent	Fisher & Paykel Allied Products , Ltd.
K871618	PREFILLED STERILE WATER FOR INHALATION, USP	May 08, 1987	Substantially Equivalent	Automatic Liquid Packaging, Inc.
K870173	LAVABED SYSTEM & CHAMBER, LAVAPAK TEMP. CONTROL	Apr 03, 1987	Substantially Equivalent	Mauna Loa Medical, Inc.
K863377	MR338 SERVO HEATED DELIVERY HUMIDIFIER	Feb 20, 1987	Substantially Equivalent	Fisher & Paykel Allied Products , Ltd.
K870055	MR590 DUAL HOSE HEATER POWER PACK	Feb 10, 1987	Substantially Equivalent	Fisher & Paykel Allied Products , Ltd.
K864173	HPD HUMIDIFYING CHAMBER	Jan 30, 1987	Substantially Equivalent	Hpd Medical, Inc.
K863154	HEATED JET HUMIDIFIER MODEL AMS-1020	Jan 12, 1987	Substantially Equivalent	Acutronic Medical Systems AG
K863955	COLBY LEVEL ALARM	Nov 07, 1986	Substantially Equivalent	Respiratory Care, Inc.
K862923	MR620 DUAL SERVO HEATED ANAESTHESIA HUMIDIFIER	Sep 23, 1986	Substantially Equivalent	Fisher & Paykel Allied Products , Ltd.
K854363	SARATOGA SCT HEATED HUMIDIFICATION SYSTEM	Dec 31, 1985	Substantially Equivalent	Saratoga Medical Instrumentation, Inc.
K851879	HEATED RESPIRATORY HUMIDIFIER	Sep 03, 1985	Substantially Equivalent	Fisher & Paykel Allied Products , Ltd.
K853146	RESPIR THER HUMID CONTAIN STERILE WATER FOR USP	Aug 06, 1985	Substantially Equivalent	Automatic Liquid Packaging, Inc.
K851940	STERILE WATER FOR INHALATION USP 2D0799	Jun 20, 1985	Substantially Equivalent	Travenol Laboratories, S.A.
K850647	HEATED RESPIRATORY HUMIFIFIER MR440	Mar 12, 1985	Substantially Equivalent	Fisher & Paykel Allied Products , Ltd.
K843903	HEATED RESPIRATORY HUMIDIFIER MR428	Oct 22, 1984	Substantially Equivalent	Fisher & Paykel Allied Products , Ltd.
K843932	VAPOR-PHASE HUMIDIFIER SYS-ADVANCED	Oct 18, 1984	Substantially Equivalent	Inspiron Corp.
K842795	MAXI-MISER HUMIDIFIER INSERT 1030	Oct 04, 1984	Substantially Equivalent	Nova-Ventrx
K842794	MAXI-MISER HUMIDIFIER INSERT 1020 & 1021	Oct 04, 1984	Substantially Equivalent	Nova-Ventrx
K841295	HYPOTHERMIA OXYGEN WARMER-TREATMENT SYS	Aug 08, 1984	Substantially Equivalent	Bow/Parm
K842340	VH820 HUMIDIFIER	Jul 17, 1984	Substantially Equivalent	Bear Medical Systems, Inc.
K842523	BIRD HEATED HUMIDIFIER 3201	Jul 11, 1984	Substantially Equivalent	3M Company
K841851	HPD HUMIDIFIER WICK	Jun 05, 1984	Substantially Equivalent	Hpd Medical, Inc.
K841158	NEBULO 28 NEBULIZER KIT	Mar 30, 1984	Substantially Equivalent	Inspiron Corp.
K834151	CONCHATHERM LHF HUMIDIFIER HEATER	Jan 13, 1984	Substantially Equivalent	Respiratory Care, Inc.
K833974	AQUAPAK 020 HUMIDIFIER ADAPTER	Dec 16, 1983	Substantially Equivalent	Respiratory Care, Inc.
K832928	SERVO HEATED RESPIRATORY HUMIDIFIER	Nov 25, 1983	Substantially Equivalent	Fisher & Paykel Allied Products , Ltd.
K831556	VAPOR-PHASE HUMIDIFIER SYSTEM	Jul 19, 1983	Substantially Equivalent	Cygnus Research Corp.
K830913	MINITROP AEROSAL, PRODOMO AEROSAL AND	May 25, 1983	Substantially Equivalent	Medlog GmbH Marketing Services
K831163	LO-COMP RESERVOIR-RE-1000	May 03, 1983	Substantially Equivalent	Cygnus Research Corp.
K823143	BUBBLE HUMIDIFIERS	Nov 29, 1982	Substantially Equivalent	Seven Harvest Intl. Import & Export
K822816	DUAL SERVO HEATED RESPIRATORY HUMIDIFIER	Oct 22, 1982	Substantially Equivalent	Fisher & Paykel Allied Products , Ltd.
K820878	CONCHO PEDIATRIC PACK	May 03, 1982	Substantially Equivalent	Rci, Inc.
K812957	EAST AUTOCLAVE HUMIDIFIER	Mar 12, 1982	Substantially Equivalent	Cairco , Ltd.
K811073	A QUAPAK	Apr 29, 1981	Substantially Equivalent	Respiratory Care, Inc.
K810939	NEBULIZER/HUMIDIFIER HUMIDITY CENTER-MI.	Apr 23, 1981	Substantially Equivalent	Allied Healthcare Products, Inc.
K810559	OPTI- SYSTEM	Mar 17, 1981	Substantially Equivalent	Corpak Co.
K810219	PREFILLED HUMIDIFER	Mar 04, 1981	Substantially Equivalent	Corpak Co.
K802852	HUMIDIFIER	Feb 26, 1981	Substantially Equivalent	Airlife, Inc.
K802145	2C 7140 HEATED HUMIDIFER CANNISTER	Sep 26, 1980	Substantially Equivalent	Travenol Laboratories, S.A.
K802144	2M8101 HEATED LIQUID LEVEL CONTROLLER	Sep 26, 1980	Substantially Equivalent	Travenol Laboratories, S.A.
K801619	MIST2GEN TEMPTROL 10	Aug 04, 1980	Substantially Equivalent	Mistogen Equipment Co.
K801252	NEBULIZER WITH AIR ENTERTAINER & ETC.	Jun 04, 1980	Substantially Equivalent	Airlife, Inc.
K800753	STERILE WATER & SALINE IN PLASTIC BTL.	Apr 24, 1980	Substantially Equivalent	Travenol Laboratories, S.A.
K800056	VENTILATOR SET	Jan 24, 1980	Substantially Equivalent	Abbott Laboratories
K792620	NEONATAL HEATED HUMIDIFIER	Jan 24, 1980	Substantially Equivalent	Modern Medical Systems Co.
K791683	STERILE WATER FOR RESPIRATORY THERAPY	Sep 17, 1979	Substantially Equivalent	Abbott Laboratories
K790731	OXYGEN HUMIDIFIER KIT	May 08, 1979	Substantially Equivalent	Abbott Laboratories
K781760	HUMIDIFIERS, MODEL:LS-420 AND LS-460	Dec 20, 1978	Substantially Equivalent	Bourns Medical Systems, Inc.
K781600	MISTY-OX PREFILLED HUMIDIFIER, DISP.	Oct 31, 1978	Substantially Equivalent	Davco
K781537	NEBULIZER/HUMIDIFIER	Oct 10, 1978	Substantially Equivalent	Chemetron Medical Products, Inc.
K781468	CONTINUOUS FEED VALVE 2D9024	Sep 07, 1978	Substantially Equivalent	Travenol Laboratories, S.A.
K780845	CONCHANEOPAK A CARTRIDGE HUMIDIFIER	Aug 14, 1978	Substantially Equivalent	Respiratory Care, Inc.
K780385	RESPIRATORY THERAPY SOLUTIONS - FLEXIBLE	May 16, 1978	Substantially Equivalent	Travenol Laboratories, S.A.
K780381	RESPIRATORY THERAPY SOLUTIONS - FLEXIBLE	May 16, 1978	Substantially Equivalent	Travenol Laboratories, S.A.
K780562	AQUAPAK PREFILLED HUMIDIFIER	Apr 27, 1978	Substantially Equivalent	Respiratory Care, Inc.
K780088	HYMIDIFIER	Feb 02, 1978	Substantially Equivalent	3M Company
K770415	HUMIDIFIER, DISPOSABLE	Apr 07, 1977	Substantially Equivalent	M.G. Humidifiers, Inc.
K770249	VENTILATOR SET - CODE 2C7109	Feb 14, 1977	Substantially Equivalent	Travenol Laboratories, S.A.
K761293	RESPIRATORY HUMIDIFIER	Jan 03, 1977	Substantially Equivalent	Harris-Lake, Inc.
K760923	HUMIDIFIER-CASCADE II	Nov 19, 1976	Substantially Equivalent	Puritan Bennett Corp.
K760938	DISPOSABLE HUMIDIFIER	Nov 09, 1976	Substantially Equivalent	Travenol Laboratories, S.A.
K760866	CONCHA-COLUMN	Nov 01, 1976	Substantially Equivalent	Respiratory Care, Inc.
K760587	U-MID PREFILLED HUMIDIFIER (300CC)	Oct 15, 1976	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K760584	U-MID PREFILLED HUMIDIFIER (500CC)	Oct 15, 1976	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K760566	PREFILLED HUMIDIFIER	Oct 15, 1976	Substantially Equivalent	Foregger Air Products & Chem., Inc.
K760372	HUMIDIFIER, DISPOSABLE	Aug 13, 1976	Substantially Equivalent	Hospitek
K760037	HEATER, IMMERSION W/ HUMIDIFIER & NEBUL.	Jul 16, 1976	Substantially Equivalent	Inspiron Corp.