ClearanceBrief
Panels › Anesthesiology › Product code BTT · Class 2

Humidifier, Respiratory Gas, (Direct Patient Interface)

Regulation 868.5450

5510(k)s in 12 months (222 all time)
1recalls in 12 months (70 all time)
66recalls that name a 510(k)
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Top companies in BTT

Decided510(k)Device and applicantCode
May 21, 2013K122705HUMICARE D900
Grundler GmbH
BTT
Jan 3, 2013K121975AIRVO HUMIDIFIER MYAIRO HUMIDIFIER
Fisher & Paykel Healthcare, Ltd., NZ
BTT
Mar 30, 2012K110019RESPIRATORY HUMIDIFER
Fisher & Paykel Healthcare, Ltd., NZ
BTT
Feb 10, 2012K113542SALTER LABS BUBBLE HUMIDIFIER (HIGH FLOW)
Salter Labs, Arvin Facility
BTT
Oct 7, 2011K111640PRECISION FLOW(R) - HELIOX
Vapotherm, Inc.
BTT
Feb 8, 2011K103316FLOWREST
Vapotherm, Inc.
BTT
Jan 27, 2011K093617VENTLAB 6000 SERIES HUMIDIFIER
Ventlab Corp.
BTT
Dec 10, 2010K102618VENTSTAR HEATED, INFINITY ID BREATHING CIRCUIT HEATED
Draeger Medical AG & Co. KG
BTT
Oct 20, 2010K092256THERA- HEAT HEATED HUMIDIFIER, MODEL RC70000, RC70072, RC70075, RC70077, RC70012
Smiths Medical Asd, Inc.
BTT
May 28, 2010K100554RESPIRATORY HUMIDIFIER , HEATED DELIVERY SYSTEM, ADAPTOR, MODELS MR880, RT241, 900MR441
Fisher & Paykel Healthcare, Ltd., NZ
BTT
Jan 27, 2010K092846AIRVO SERIES HUMIDIFIERS
Fisher & Paykel Healthcare, Ltd., NZ
BTT
Nov 18, 2009K090915STERILE WATER FOR INHALATION FLEX BAG, USP
Cardinal Health, Inc.
BTT
Dec 18, 2008K080149HEATER BASE, MODEL PMH7000
Pacific Medico Co., Ltd., JP
BTT
Jul 17, 2008K072845PRECISION FLOW
Vapotherm, Inc.
BTT
Jul 9, 2008K080797HUMIDAIRE 2I
Resmed, Ltd.
BTT
Mar 31, 2008K073706RESPIRATORY HUMIDIFIER, MODEL MR850
Fisher & Paykel Healthcare, Ltd., NZ
BTT
Nov 29, 2007K072982PARI HYDRATE V
Pari Innovative Manufacturers, Inc.
BTT
Nov 21, 2007K071958THERA-HEAT HEATED HUMIDIFIER AND ADULT DUAL AND SINGLE LIMB HEATED WIRE VENTILATOR BREATHING CIRCUITS
Smiths Medical Asd, Inc.
BTT
Apr 30, 2007K070714MEDISIZE GOLD HEATER AND BOOSTER
Medisize BV, NL
BTT
Apr 23, 2007K063758CHONCHA THERM NEPTUNE HEATED HUMIFIER, CHONCHA THERM NEPTUNE HEATED HUMIFIER (REMANUFACTURER), MODEL# 425-00,425-00R
Teleflex Medical
BTT
Apr 13, 2007K070056VAPOTHERM MODEL# 2000I AND 2000H
Vapotherm, Inc.
BTT
Feb 23, 2007K070107PARI HYDRATE G
Pari Innovative Manufacturers, Inc.
BTT
Dec 6, 2006K062664HUMIDCARE HEATED HUMIDIFIER, MODEL 9S-004
Apex Medical Corp., TW
BTT
Aug 18, 2006K061736COMFORT FLO HUMIDIFICATION SYSTEM AND NASAL CANNULA
Teleflex Medical
BTT
Aug 8, 2006K062091POROUS MEDIA HUMIDIFLOW HUMIDIFIER FOR UNIVERSAL HUMIDIFICATION
Porous Media Corp.
BTT
May 25, 2006K060790BREAS, MODEL HA01
Breas Medical AB, SE
BTT
Dec 9, 2005K052615MEDISIZE GOLD
Medisize BV, NL
BTT
May 2, 2005K050990REMREST HEATED HUMIDIFIER
Medical Industries America, Inc.
BTT
Feb 18, 2005K050314AQUINOX
Smiths Medical Asd, Inc.
BTT
Jan 10, 2005K042184GOODKNIGHT H20, MODEL M-114600-00
Mallinckrodt Developpement France, FR
BTT
Oct 20, 2004K041963AMERICAN BANTEX HUMIDIFIER, DRY, BUBBLE, MODELS B9000, 3 PSI AND B9100, 6 PSI
American Bantex Corp.
BTT
Aug 30, 2004K042245VAPOTHERM MODEL#2000I, 200H
Vapotherm, Inc.
BTT
Apr 26, 2004K020700PMH 5000 HEATED HUMIDIFIER FOR RESPIRATORY THERAPY
Pegasus Research Corp.
BTT
Apr 13, 2004K033710MR850 RESPIRATORY HUMIDIFIER, MODEL MR850JHU
Fisher & Paykel Healthcare, Ltd., NZ
BTT
Mar 25, 2004K031176INVACARE POLARIS EX HEATED HUMIDIFIER, MODEL ISP4000
Invacare Corp.
BTT
Mar 4, 2004K040507TAGA VELOCITY PASSOVER HUMIDIFIER WITH HEATER, MODEL TM1000H
Taga Medical Technologies, Inc.
BTT
Jul 17, 2003K031179TAGA VELOCITY HUMIDIFIER
Taga Medical Technologies, Inc.
BTT
Jul 7, 2003K031383MODEL 780
Hudson Respiratory Care, Inc.
BTT
Jul 7, 2003K020332RESPIRATORY HUMIDIFIER, MODEL MR850
Fisher & Paykel Healthcare, Ltd., NZ
BTT
May 30, 2003K013486VAPOTHERM 2000H
Vapotherm, Inc.
BTT
Feb 21, 2003K013856PMH 1000 HEATED HUMIDIFIER
Pegasus Research Corp.
BTT
Jan 24, 2003K030090H2 HEATED HUMIDIFIER
Respironics, Inc.
BTT
Jun 3, 2002K020900DEVILBISS MODEL 9200D HEATED HUMIDIFIER SYSTEM
Sunrise Medical Hhg, Inc.
BTT
Feb 28, 2002K012633RESPIRONICS HEATED HUMIDIFIER
Respironics, Inc.
BTT
Jun 1, 2001K003973RESPIRATORY HUMIDIFIER, MODEL HC150
Fisher & Paykel Healthcare, Ltd., NZ
BTT
May 4, 2001K003626DEVILBISS HUMIDIFIER
Sunrise Medical Hhg, Inc.
BTT
Apr 25, 2001K010578TAGA VELOCITY PASSOVER HUMIDIFIER UNIT, MODEL MP1017
Taga Medical Technologies, Inc.
BTT
Apr 17, 2001K003561INVACARE PASSOVER HUMIDIFIER MODEL ISP9700
Invacare Corp.
BTT
Mar 14, 2001K010402SMOOTH-FLO CIRCUIT
Hudson Respiratory Care, Inc.
BTT
Mar 7, 2001K002454BREAS HA50 HUMIDIFIER, MODEL HA50
Vital Signs, Inc.
BTT

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