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 |
| K213191 | Barkey GmbH & Co. KG | S-Line | 05/24/2022 |
| K032674 | BELMONT INSTRUMENT CORP. | BELMONT FLUID MANAGEMENT SYSTEM, MODEL FMS2000 | 09/16/2003 |
| K090089 | BELMONT INSTRUMENT CORP. | BELMONT HYPERTHERMIA PUMP | 02/12/2009 |
| K131519 | BELMONT INSTRUMENT CORP. | BELMONT HYPERTHERMIA PUMP | 11/06/2013 |
| 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 |
| K150484 | Creche Innovations | Penguin In-Line Warmer | 07/09/2015 |
| 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 |
| K192325 | Life Warmer, Inc. | Quantum Blood and Fluid Warming System | 10/18/2019 |
| K181775 | Life Warmer, Inc. | Quantum Blood and IV Fluid Infusion Warmer | 01/28/2019 |
| K180842 | MAC Medical Inc. | MAC Medical D-Series Blanket and Solution Warming Cabinets | 03/05/2019 |
| 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 |
| 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 |
| 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 |
| 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 |
| K211800 | Quality in Flow Ltd. | Warrior Blood and Fluid Warmer, Warrior EXTREME Blood and Fluid Warmer, Warrior Lite Blood and Fluid Warmer | 12/08/2022 |
| 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 |
| K202461 | Smisson-Cartledge Biomedical LLC | ThermaCor 1200 Disposable Sets for the ThermaCor 1200 Rapid Thermal Infusion System | 08/12/2022 |
| 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 |
| 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 |
| K211618 | The Surgical Company International B.V. | Fluido Compact Blood and Fluid Warming System | 06/05/2023 |
| 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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