FDA 510(k) Applications for Medical Device Product Code "LGZ"
(Warmer, Thermal, Infusion Fluid)

FDA 510(k) Number Applicant Device Name Decision Date
K122449 ACACIA, INC. ENTERAL NUTRITION WARMER 06/13/2013
K060939 ARIZANT HEALTHCARE INC. RANGER IRRIGATION FLUID WARMING SYSTEM 06/26/2006
K082217 ARIZANT HEALTHCARE INC. RANGER RAPID FLOW BLOOD/FLUID WARMING SYSTEM 10/06/2008
K023653 AUTOMATIC MEDICAL TECHNOLOGIES, INC. MAXONE IV FLUID/BLOOD WARMER, MODEL 102 01/17/2003
K002409 AUTOMATIC MEDICAL TECHNOLOGIES, INC. MAXONE, BLOOD, BLOOD PRODUCTS AND IV FLUID WARMER 06/28/2001
K032674 BELMONT INSTRUMENT CORP. BELMONT FLUID MANAGEMENT SYSTEM, MODEL FMS2000 09/16/2003
K131519 BELMONT INSTRUMENT CORP. BELMONT HYPERTHERMIA PUMP 11/06/2013
K090089 BELMONT INSTRUMENT CORP. BELMONT HYPERTHERMIA PUMP 02/12/2009
K070654 BELMONT INSTRUMENT CORP. HYPERTHERMIA PUMP 06/08/2007
K032778 BELMONT INSTRUMENT CORP. LARGE VOLUME FLUID RESERVOIR 09/22/2003
K152208 BELMONT INSTRUMENT CORPORATION The Belmont Hyperthermia Pump 09/02/2015
K121198 BIEGLER GMBH BW685, BW685S 07/12/2012
K954769 BIEGLER MEDICAL PRODUCTS, INC. BIEGLER BW385L BLOOD & INFUSION WARMER 08/08/1996
K955659 C.F. ELECTRONICS, INC. DRUGBOX 05/14/1996
K921395 C.F. ELECTRONICS, INC. HOT SACK 09/02/1992
K922786 C.F. ELECTRONICS, INC. THERM O DRUG MODEL HT-747 01/27/1993
K150484 Creche Innovations Penguin In-Line Warmer 07/09/2015
K813161 DATACHEM, INC. FLO TEM II (BLOOD/FLUID WARMER 12/09/1981
K803249 DATACHEM, INC. FLUID WARMER 05/21/1981
K822098 ELECTROMEDICS, INC. BT 794-BLOOD/FLUID WARMER 08/20/1982
K012906 ELLTEC CO., LTD. ANIMEC, MODELS AM-2S-4 AND AM-2S-5 10/09/2001
K024373 ELLTEC CO., LTD. MODIFICATION TO ANIMEC, MODELS AM-2S-4, AM-2S-5, LT-1-4 & LT-1-5 01/28/2003
K103801 EMIT CORPORATION HYPOTHERMX INTRAVENOUS FLUID WARMER 05/20/2011
K060537 ENGINIVITY LLC EFLOW IV FLUID WARMER, MODEL 100, EFLOW DISPOSABLE CARTRIDGE, MODEL 200 AND EFLOW AC POWER SUPPLY, MODEL 120 06/08/2006
K132202 ENTHERMICS MEDICAL SYSTEMS, INC. DC SERIES FLUID WARMING CABINET, DC SERIES FLUID WARMING CABINET 12/06/2013
K091336 ENTHERMICS MEDICAL SYSTEMS, INC. IVNOW MODULAR FLUID WARMER, 120V, MODEL IVNOW-1, IVNOW-2, IVNOW-3, IVNOW-6, IVNOW MODULAR FLUID WARMER 230V 05/07/2010
K102900 HEI, INC. HEITER 3000 HYPERTHERMIC PERFUSION SYSTEM 03/21/2012
K112702 IMPERIAL SURGICAL LTD. IMPERIAL SURGICAL LTD. BLANKEY AND SOLUTION WARNING CABINETS 03/29/2012
K911383 LEVEL 1 TECHNOLOGIES, INC. HOTLINE FLUID WARMER 10/17/1991
K896018 MEDADVANCES, INC. BIOTEMP 02/09/1990
K904252 MEDADVANCES, INC. HEATWAVE 10/15/1990
K981509 MEDICAL PRODUCTS, INC. TEMPO III 07/10/1998
K120860 MEDICAL RESCUE EQUIPMENT HOLDING AS INFU BOX TYPE 0412A 05/08/2012
K041839 MEDICAL SOLUTIONS, INC. 8NONE 02/15/2005
K980086 MEDICAL SOLUTIONS, INC. HEAT STACK 03/10/1998
K012276 MEDICAL SOLUTIONS, INC. TEMP 3 08/20/2001
K062644 MERLYN ASSOCIATES, INC. FLEXWARMER, MODELS KZ-1 AND KZ-2 09/11/2007
K914867 MICROWAVE MEDICAL SYSTEMS, INC. QWIK-1(TM) IN-LINE IV FLUID WARMER 10/23/1992
K031390 MINIMED, INC. MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODEL MMT-712 07/23/2003
K132110 NATUS NICOLET IRELAND LTD NATUS WARMETTE BLANKET AND DUAL CABINETS 10/03/2013
K914364 NORTH AMERICAN TECHNICAL SERVICES CORP. ASTOTHERM IFT 250, IFT 260, ASTOTUBE VARIOUS NO. 09/10/1992
K012832 NXSTAGE MEDICAL, INC. COMFORTMATE FLUID WARMING SYSTEM, MODEL # FW-200; COMFORTMATE DISPORSABLE DISPOSABLE WARMING SET, MODEL #FWS-200 10/24/2001
K073363 PALADIN BIOMEDICAL CORPORATION THERMOSTAT 900 ADMINISTRATION SET, MODEL ASH 100, 200 AND 300 03/20/2008
K883873 PMT CORP. INFUSION FLUID WARMER 02/28/1989
K150404 Quality in Flow Ltd. QiF Blood and Fluid Warmer 06/23/2016
K163708 Quality In Flow Ltd. QiF Blood and Fluid Warmer 04/20/2017
K171215 Quality In Flow Ltd. QiF Blood and Fluid Warmer 09/27/2017
K180154 Quality In Flow Ltd. QiF Blood and Fluid Warmer 04/27/2018
K161613 RanD S.r.l. Hang&Go PAC 12/28/2016
K120026 RAND S.R.L. PERFORMER HT/ HANG&GO HT BASIC 05/08/2012
K001764 SIMS LEVEL 1, INC. HOTLINE 2 FLUID WARMER 08/09/2000
K052055 SMISSON-CARTLEDGE BIOMEDICAL LLC SMISSON-CARTLEDGE THERMAL INFUSION SYSTEM, MODEL TIS-1200 10/26/2006
K973748 SMITH TEMPO AND TEMP H20 03/10/1998
K072080 SMITHS MEDICAL ASD, INC. NORMOFLO IRRIGATION FLUID WARMER, MODELS H-1100, H-1129, NORMOFLO IRRIGATION WARMING SET, MODELS, IR-40, IR-500, IR-600, 06/02/2008
K110769 STERIS Corporation AMSCO WARMING CABINET 06/03/2011
K092823 STERIS Corporation AMSCO WARMING CABINET 12/18/2009
K111870 STERIS Corporation AMSCO WARMING CABINET 07/29/2011
K082765 STIHLER ELECTRONIC GMBH ASTOFLO PLUS 12/18/2008
K882361 STIHLER ELECTRONIC, C/O WORLDWIDE REGUL. SERVICES STIHLER ASTOTHERM IFT 200, IFT 220 08/25/1988
K060851 THE SMITHWORKS COMPANY SOFT SACK IV FLUID WARMER, THE FLOORMOUNT IV FLUID WARMER, THE PAK 2 IV WARMER AND THE THERMAL SAC PRESSURE INFUSER 12/22/2006
K092366 THERMAL THERAPEUTIC SYSTEMS, INC TTS100 PORTABLE HYPERTHERMIC PERFUSION DEVICE 03/04/2010
K112902 VITAL SIGNS, INC. ENFLOW IV FLUID WARMER 03/14/2012
K130867 VITAL SIGNS, INC., A GE HEALTHCARE COMPANY ENFLOW IV FLUID WARMER INSULATED STRAP 06/14/2013
K121775 VITAL SIGNS, INC., A GE HEALTHCARE COMPANY ENFLOW IV FLUID WARMER, ENFLOW DISPOSABLE CARTRIDGE, ENFLOW CONTROLLER 11/28/2012


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