Atlas FDA

LGZ

75 FDA 510(k) clearances · Product code

126 daysmedian time to decision
366 days90th percentile
75clearances measured

FDA profile

Official device name
Warmer, Thermal, Infusion Fluid
Device class
Class II (moderate risk)
Regulation
21 CFR 880.5725
Medical specialty
General Hospital
Adverse events (MAUDE)
2021: 885 · 2022: 1,548 · 2023: 1,033 · 2024: 862 · 2025: 380 · 2026: 65
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
°M Warmer System with °M Station (K260988)Mequ A/S2026-04-24
Fluido Compact System (K252636)The Surgical Company International B.V.2025-11-18
Fluido® AirGuard System (K251733)The Surgical Company International BV (As Tsc Life)2025-09-04
°M Warmer System (K232107)Mequ A/S2024-05-31
Fluido Compact Blood and Fluid Warming System (K211618)The Surgical Company International B.V.2023-06-05
Warrior Blood and Fluid Warmer, Warrior EXTREME Blood and Fluid Warmer, Warrior Lite Blood and Fluid Warmer (K211800)Quality IN Flow , Ltd.2022-12-08
ThermaCor 1200 Disposable Sets for the ThermaCor 1200 Rapid Thermal Infusion System (K202461)Smisson-Cartledge Biomedical, LLC2022-08-12
S-Line (K213191)Barkey GmbH & Co. KG2022-05-24
Quantum Blood and Fluid Warming System (K192325)Life Warmer, Inc.2019-10-18
MAC Medical D-Series Blanket and Solution Warming Cabinets (K180842)Mac Medical, Inc.2019-03-05
Quantum Blood and IV Fluid Infusion Warmer (K181775)Life Warmer, Inc.2019-01-28
QiF Blood and Fluid Warmer (K180154)Quality IN Flow , Ltd.2018-04-27
QiF Blood and Fluid Warmer (K171215)Quality IN Flow , Ltd.2017-09-27
QiF Blood and Fluid Warmer (K163708)Quality IN Flow , Ltd.2017-04-20
Hang&Go PAC (K161613)Rand S.R.L.2016-12-28
QiF Blood and Fluid Warmer (K150404)Quality IN Flow , Ltd.2016-06-23
The Belmont Hyperthermia Pump (K152208)Belmont Instrument Corporation2015-09-02
Penguin In-Line Warmer (K150484)Creche Innovations2015-07-09
DC SERIES FLUID WARMING CABINET, DC SERIES FLUID WARMING CABINET (K132202)Enthermics Medical Systems, Inc.2013-12-06
BELMONT HYPERTHERMIA PUMP (K131519)Belmont Instrument Corp.2013-11-06
NATUS WARMETTE BLANKET AND DUAL CABINETS (K132110)Natus Nicolet Ireland, Ltd.2013-10-03
ENFLOW IV FLUID WARMER INSULATED STRAP (K130867)Vital Signs, Inc., A GE Healthcare Company2013-06-14
ENTERAL NUTRITION WARMER (K122449)Acacia, Inc.2013-06-13
ENFLOW IV FLUID WARMER, ENFLOW DISPOSABLE CARTRIDGE, ENFLOW CONTROLLER (K121775)Vital Signs, Inc., A GE Healthcare Company2012-11-28
BW685, BW685S (K121198)Biegler GmbH2012-07-12
PERFORMER HT/ HANG&GO HT BASIC (K120026)Rand S.R.L.2012-05-08
INFU BOX TYPE 0412A (K120860)Medical Rescue Equipment Holding AS2012-05-08
IMPERIAL SURGICAL LTD. BLANKEY AND SOLUTION WARNING CABINETS (K112702)Imperial Surgical , Ltd.2012-03-29
HEITER 3000 HYPERTHERMIC PERFUSION SYSTEM (K102900)Hei, Inc.2012-03-21
ENFLOW IV FLUID WARMER (K112902)Vital Signs, Inc.2012-03-14
AMSCO WARMING CABINET (K111870)STERIS Corporation2011-07-29
AMSCO WARMING CABINET (K110769)STERIS Corporation2011-06-03
HYPOTHERMX INTRAVENOUS FLUID WARMER (K103801)Emit Corporation2011-05-20
IVNOW MODULAR FLUID WARMER, 120V, MODEL IVNOW-1, IVNOW-2, IVNOW-3, IVNOW-6, IVNOW MODULAR FLUID WARMER 230V (K091336)Enthermics Medical Systems, Inc.2010-05-07
TTS100 PORTABLE HYPERTHERMIC PERFUSION DEVICE (K092366)Thermal Therapeutic Systems, Inc.2010-03-04
AMSCO WARMING CABINET (K092823)STERIS Corporation2009-12-18
BELMONT HYPERTHERMIA PUMP (K090089)Belmont Instrument Corp.2009-02-12
ASTOFLO PLUS (K082765)Stihler Electronic GmbH2008-12-18
RANGER RAPID FLOW BLOOD/FLUID WARMING SYSTEM (K082217)Arizant Healthcare, Inc.2008-10-06
NORMOFLO IRRIGATION FLUID WARMER, MODELS H-1100, H-1129, NORMOFLO IRRIGATION WARMING SET, MODELS, IR-40, IR-500, IR-600, (K072080)Smiths Medical Asd, Inc.2008-06-02
THERMOSTAT 900 ADMINISTRATION SET, MODEL ASH 100, 200 AND 300 (K073363)Paladin Biomedical Corporation2008-03-20
FLEXWARMER, MODELS KZ-1 AND KZ-2 (K062644)Merlyn Associates, Inc.2007-09-11
HYPERTHERMIA PUMP (K070654)Belmont Instrument Corp.2007-06-08
SOFT SACK IV FLUID WARMER, THE FLOORMOUNT IV FLUID WARMER, THE PAK 2 IV WARMER AND THE THERMAL SAC PRESSURE INFUSER (K060851)The Smithworks Company2006-12-22
SMISSON-CARTLEDGE THERMAL INFUSION SYSTEM, MODEL TIS-1200 (K052055)Smisson-Cartledge Biomedical, LLC2006-10-26
RANGER IRRIGATION FLUID WARMING SYSTEM (K060939)Arizant Healthcare, Inc.2006-06-26
EFLOW IV FLUID WARMER, MODEL 100, EFLOW DISPOSABLE CARTRIDGE, MODEL 200 AND EFLOW AC POWER SUPPLY, MODEL 120 (K060537)Enginivity, LLC2006-06-08
8NONE (K041839)Medical Solutions, Inc.2005-02-15
LARGE VOLUME FLUID RESERVOIR (K032778)Belmont Instrument Corp.2003-09-22
BELMONT FLUID MANAGEMENT SYSTEM, MODEL FMS2000 (K032674)Belmont Instrument Corp.2003-09-16
MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODEL MMT-712 (K031390)Minimed, Inc.2003-07-23
MODIFICATION TO ANIMEC, MODELS AM-2S-4, AM-2S-5, LT-1-4 & LT-1-5 (K024373)Elltec Co., Ltd.2003-01-28
MAXONE IV FLUID/BLOOD WARMER, MODEL 102 (K023653)Automatic Medical Technologies, Inc.2003-01-17
COMFORTMATE FLUID WARMING SYSTEM, MODEL # FW-200; COMFORTMATE DISPORSABLE DISPOSABLE WARMING SET, MODEL #FWS-200 (K012832)Nxstage Medical, Inc.2001-10-24
ANIMEC, MODELS AM-2S-4 AND AM-2S-5 (K012906)Elltec Co., Ltd.2001-10-09
TEMP 3 (K012276)Medical Solutions, Inc.2001-08-20
MAXONE, BLOOD, BLOOD PRODUCTS AND IV FLUID WARMER (K002409)Automatic Medical Technologies, Inc.2001-06-28
HOTLINE 2 FLUID WARMER (K001764)Sims Level 1, Inc.2000-08-09
TEMPO III (K981509)Medical Products, Inc.1998-07-10
TEMPO AND TEMP H20 (K973748)Smith1998-03-10
HEAT STACK (K980086)Medical Solutions, Inc.1998-03-10
BIEGLER BW385L BLOOD & INFUSION WARMER (K954769)Biegler Medical Products, Inc.1996-08-08
DRUGBOX (K955659)C.F. Electronics, Inc.1996-05-14
THERM O DRUG MODEL HT-747 (K922786)C.F. Electronics, Inc.1993-01-27
QWIK-1(TM) IN-LINE IV FLUID WARMER (K914867)Microwave Medical Systems, Inc.1992-10-23
ASTOTHERM IFT 250, IFT 260, ASTOTUBE VARIOUS NO. (K914364)North American Technical Services Corp.1992-09-10
HOT SACK (K921395)C.F. Electronics, Inc.1992-09-02
HOTLINE FLUID WARMER (K911383)Level 1 Technologies, Inc.1991-10-17
HEATWAVE (K904252)Medadvances, Inc.1990-10-15
BIOTEMP (K896018)Medadvances, Inc.1990-02-09
INFUSION FLUID WARMER (K883873)Pmt Corp.1989-02-28
STIHLER ASTOTHERM IFT 200, IFT 220 (K882361)Stihler Electronic, C/O Worldwide Regul. Services1988-08-25
BT 794-BLOOD/FLUID WARMER (K822098)Electromedics, Inc.1982-08-20
FLO TEM II (BLOOD/FLUID WARMER (K813161)Datachem, Inc.1981-12-09
FLUID WARMER (K803249)Datachem, Inc.1981-05-21

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Every clearance here is in the API, with alerts when new ones post.