Product Code: LGZ FDA class 2 21 CFR 880.5725

Warmer, Thermal, Infusion Fluid

General Hospital

A thermal infusion fluid warmer is a device used to warm intravenous fluids and blood products to near body temperature before or during administration to patients, reducing the risk of hypothermia associated with the transfusion of cold fluids in clinical settings. The device is FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance. It carries product code LGZ and is regulated under 21 CFR 880.5725 within the General Hospital specialty. No special flags apply to this device.

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FEI Numbers

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Basic Information

Product Code: LGZ
Device Class: FDA class 2
Regulation Number: 880.5725
Medical Specialty: General Hospital
Review Panel: HO
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 75 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K260988	°M Warmer System with °M Station	Apr 24, 2026	Substantially Equivalent	Mequ A/S
K252636	Fluido Compact System	Nov 18, 2025	Substantially Equivalent	The Surgical Company International B.V.
K251733	Fluido® AirGuard System	Sep 04, 2025	Substantially Equivalent	The Surgical Company International BV (As Tsc Life)
K232107	°M Warmer System	May 31, 2024	Substantially Equivalent	Mequ A/S
K211618	Fluido Compact Blood and Fluid Warming System	Jun 05, 2023	Substantially Equivalent	The Surgical Company International B.V.
K211800	Warrior Blood and Fluid Warmer, Warrior EXTREME Blood and Fluid Warmer, Warrior Lite Blood and Fluid Warmer	Dec 08, 2022	Substantially Equivalent	Quality IN Flow , Ltd.
K202461	ThermaCor 1200 Disposable Sets for the ThermaCor 1200 Rapid Thermal Infusion System	Aug 12, 2022	Substantially Equivalent	Smisson-Cartledge Biomedical, LLC
K213191	S-Line	May 24, 2022	Substantially Equivalent	Barkey GmbH & Co. KG
K192325	Quantum Blood and Fluid Warming System	Oct 18, 2019	Substantially Equivalent	Life Warmer, Inc.
K180842	MAC Medical D-Series Blanket and Solution Warming Cabinets	Mar 05, 2019	Substantially Equivalent	Mac Medical, Inc.
K181775	Quantum Blood and IV Fluid Infusion Warmer	Jan 28, 2019	Substantially Equivalent	Life Warmer, Inc.
K180154	QiF Blood and Fluid Warmer	Apr 27, 2018	Substantially Equivalent	Quality IN Flow , Ltd.
K171215	QiF Blood and Fluid Warmer	Sep 27, 2017	Substantially Equivalent	Quality IN Flow , Ltd.
K163708	QiF Blood and Fluid Warmer	Apr 20, 2017	Substantially Equivalent	Quality IN Flow , Ltd.
K161613	Hang&Go PAC	Dec 28, 2016	Substantially Equivalent	Rand S.R.L.
K150404	QiF Blood and Fluid Warmer	Jun 23, 2016	Substantially Equivalent	Quality IN Flow , Ltd.
K152208	The Belmont Hyperthermia Pump	Sep 02, 2015	Substantially Equivalent	Belmont Instrument Corporation
K150484	Penguin In-Line Warmer	Jul 09, 2015	Substantially Equivalent	Creche Innovations
K132202	DC SERIES FLUID WARMING CABINET, DC SERIES FLUID WARMING CABINET	Dec 06, 2013	Substantially Equivalent	Enthermics Medical Systems, Inc.
K131519	BELMONT HYPERTHERMIA PUMP	Nov 06, 2013	Substantially Equivalent	Belmont Instrument Corp.
K132110	NATUS WARMETTE BLANKET AND DUAL CABINETS	Oct 03, 2013	Substantially Equivalent	Natus Nicolet Ireland, Ltd.
K130867	ENFLOW IV FLUID WARMER INSULATED STRAP	Jun 14, 2013	Substantially Equivalent	Vital Signs, Inc., A GE Healthcare Company
K122449	ENTERAL NUTRITION WARMER	Jun 13, 2013	Substantially Equivalent	Acacia, Inc.
K121775	ENFLOW IV FLUID WARMER, ENFLOW DISPOSABLE CARTRIDGE, ENFLOW CONTROLLER	Nov 28, 2012	Substantially Equivalent	Vital Signs, Inc., A GE Healthcare Company
K121198	BW685, BW685S	Jul 12, 2012	Substantially Equivalent	Biegler GmbH
K120860	INFU BOX TYPE 0412A	May 08, 2012	Substantially Equivalent	Medical Rescue Equipment Holding AS
K120026	PERFORMER HT/ HANG&GO HT BASIC	May 08, 2012	Substantially Equivalent	Rand S.R.L.
K112702	IMPERIAL SURGICAL LTD. BLANKEY AND SOLUTION WARNING CABINETS	Mar 29, 2012	Substantially Equivalent	Imperial Surgical , Ltd.
K102900	HEITER 3000 HYPERTHERMIC PERFUSION SYSTEM	Mar 21, 2012	Substantially Equivalent	Hei, Inc.
K112902	ENFLOW IV FLUID WARMER	Mar 14, 2012	Substantially Equivalent	Vital Signs, Inc.
K111870	AMSCO WARMING CABINET	Jul 29, 2011	Substantially Equivalent	STERIS Corporation
K110769	AMSCO WARMING CABINET	Jun 03, 2011	Substantially Equivalent	STERIS Corporation
K103801	HYPOTHERMX INTRAVENOUS FLUID WARMER	May 20, 2011	Substantially Equivalent	Emit Corporation
K091336	IVNOW MODULAR FLUID WARMER, 120V, MODEL IVNOW-1, IVNOW-2, IVNOW-3, IVNOW-6, IVNOW MODULAR FLUID WARMER 230V	May 07, 2010	Substantially Equivalent	Enthermics Medical Systems, Inc.
K092366	TTS100 PORTABLE HYPERTHERMIC PERFUSION DEVICE	Mar 04, 2010	Substantially Equivalent	Thermal Therapeutic Systems, Inc.
K092823	AMSCO WARMING CABINET	Dec 18, 2009	Substantially Equivalent	STERIS Corporation
K090089	BELMONT HYPERTHERMIA PUMP	Feb 12, 2009	Substantially Equivalent	Belmont Instrument Corp.
K082765	ASTOFLO PLUS	Dec 18, 2008	Substantially Equivalent	Stihler Electronic GmbH
K082217	RANGER RAPID FLOW BLOOD/FLUID WARMING SYSTEM	Oct 06, 2008	Substantially Equivalent	Arizant Healthcare, Inc.
K072080	NORMOFLO IRRIGATION FLUID WARMER, MODELS H-1100, H-1129, NORMOFLO IRRIGATION WARMING SET, MODELS, IR-40, IR-500, IR-600,	Jun 02, 2008	Substantially Equivalent	Smiths Medical Asd, Inc.
K073363	THERMOSTAT 900 ADMINISTRATION SET, MODEL ASH 100, 200 AND 300	Mar 20, 2008	Substantially Equivalent	Paladin Biomedical Corporation
K062644	FLEXWARMER, MODELS KZ-1 AND KZ-2	Sep 11, 2007	Substantially Equivalent	Merlyn Associates, Inc.
K070654	HYPERTHERMIA PUMP	Jun 08, 2007	Substantially Equivalent	Belmont Instrument Corp.
K060851	SOFT SACK IV FLUID WARMER, THE FLOORMOUNT IV FLUID WARMER, THE PAK 2 IV WARMER AND THE THERMAL SAC PRESSURE INFUSER	Dec 22, 2006	Substantially Equivalent	The Smithworks Company
K052055	SMISSON-CARTLEDGE THERMAL INFUSION SYSTEM, MODEL TIS-1200	Oct 26, 2006	Substantially Equivalent	Smisson-Cartledge Biomedical, LLC
K060939	RANGER IRRIGATION FLUID WARMING SYSTEM	Jun 26, 2006	Substantially Equivalent	Arizant Healthcare, Inc.
K060537	EFLOW IV FLUID WARMER, MODEL 100, EFLOW DISPOSABLE CARTRIDGE, MODEL 200 AND EFLOW AC POWER SUPPLY, MODEL 120	Jun 08, 2006	Substantially Equivalent	Enginivity, LLC
K041839	8NONE	Feb 15, 2005	Substantially Equivalent	Medical Solutions, Inc.
K032778	LARGE VOLUME FLUID RESERVOIR	Sep 22, 2003	Substantially Equivalent	Belmont Instrument Corp.
K032674	BELMONT FLUID MANAGEMENT SYSTEM, MODEL FMS2000	Sep 16, 2003	Substantially Equivalent	Belmont Instrument Corp.
K031390	MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODEL MMT-712	Jul 23, 2003	Substantially Equivalent	Minimed, Inc.
K024373	MODIFICATION TO ANIMEC, MODELS AM-2S-4, AM-2S-5, LT-1-4 & LT-1-5	Jan 28, 2003	Substantially Equivalent	Elltec Co., Ltd.
K023653	MAXONE IV FLUID/BLOOD WARMER, MODEL 102	Jan 17, 2003	Substantially Equivalent	Automatic Medical Technologies, Inc.
K012832	COMFORTMATE FLUID WARMING SYSTEM, MODEL # FW-200; COMFORTMATE DISPORSABLE DISPOSABLE WARMING SET, MODEL #FWS-200	Oct 24, 2001	Substantially Equivalent	Nxstage Medical, Inc.
K012906	ANIMEC, MODELS AM-2S-4 AND AM-2S-5	Oct 09, 2001	Substantially Equivalent	Elltec Co., Ltd.
K012276	TEMP 3	Aug 20, 2001	Substantially Equivalent	Medical Solutions, Inc.
K002409	MAXONE, BLOOD, BLOOD PRODUCTS AND IV FLUID WARMER	Jun 28, 2001	Substantially Equivalent	Automatic Medical Technologies, Inc.
K001764	HOTLINE 2 FLUID WARMER	Aug 09, 2000	Substantially Equivalent	Sims Level 1, Inc.
K981509	TEMPO III	Jul 10, 1998	Substantially Equivalent	Medical Products, Inc.
K980086	HEAT STACK	Mar 10, 1998	Substantially Equivalent	Medical Solutions, Inc.
K973748	TEMPO AND TEMP H20	Mar 10, 1998	Substantially Equivalent	Smith
K954769	BIEGLER BW385L BLOOD & INFUSION WARMER	Aug 08, 1996	Substantially Equivalent	Biegler Medical Products, Inc.
K955659	DRUGBOX	May 14, 1996	Substantially Equivalent	C.F. Electronics, Inc.
K922786	THERM O DRUG MODEL HT-747	Jan 27, 1993	Substantially Equivalent	C.F. Electronics, Inc.
K914867	QWIK-1(TM) IN-LINE IV FLUID WARMER	Oct 23, 1992	Substantially Equivalent	Microwave Medical Systems, Inc.
K914364	ASTOTHERM IFT 250, IFT 260, ASTOTUBE VARIOUS NO.	Sep 10, 1992	Substantially Equivalent	North American Technical Services Corp.
K921395	HOT SACK	Sep 02, 1992	Substantially Equivalent	C.F. Electronics, Inc.
K911383	HOTLINE FLUID WARMER	Oct 17, 1991	Substantially Equivalent	Level 1 Technologies, Inc.
K904252	HEATWAVE	Oct 15, 1990	Substantially Equivalent	Medadvances, Inc.
K896018	BIOTEMP	Feb 09, 1990	Substantially Equivalent	Medadvances, Inc.
K883873	INFUSION FLUID WARMER	Feb 28, 1989	Substantially Equivalent	Pmt Corp.
K882361	STIHLER ASTOTHERM IFT 200, IFT 220	Aug 25, 1988	Substantially Equivalent	Stihler Electronic, C/O Worldwide Regul. Services
K822098	BT 794-BLOOD/FLUID WARMER	Aug 20, 1982	Substantially Equivalent	Electromedics, Inc.
K813161	FLO TEM II (BLOOD/FLUID WARMER	Dec 09, 1981	Substantially Equivalent	Datachem, Inc.
K803249	FLUID WARMER	May 21, 1981	Substantially Equivalent	Datachem, Inc.