Panels › General Hospital › Product code LGZ · Class 2
Warmer, Thermal, Infusion Fluid
Regulation 880.5725
3510(k)s in 12 months (76 all time)
1recalls in 12 months (33 all time)
31recalls that name a 510(k)
Top companies in LGZ
| Company | 510(k)s | Recalls |
|---|---|---|
| Smiths Medical Asd, Inc. | 1 | 13 |
| Belmont Instrument Corp. | 6 | 4 |
| Quality IN Flow , Ltd. | 5 | 0 |
| Smisson-Cartledge Biomedical, LLC | 2 | 3 |
| Rand S.R.L. | 2 | 2 |
| STERIS Corporation | 3 | 1 |
| C.F. Electronics, Inc. | 3 | 0 |
| Medical Solutions, Inc. | 3 | 0 |
| Arizant Healthcare, Inc. | 2 | 0 |
| Automatic Medical Technologies, Inc. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 18, 2026 | K262532 | NORMOFLO Irrigation Fluid Warming Sets and Accessories (IR-601, IR-501, IR-61, PL-61) ICU Medical | LGZ |
| Apr 24, 2026 | K260988 | °M Warmer System with °M Station Mequ A/S, DK | LGZ |
| Nov 18, 2025 | K252636 | Fluido Compact System The Surgical Company International B.V., NL | LGZ |
| Sep 4, 2025 | K251733 | Fluido® AirGuard System The Surgical Company International BV (As Tsc Life), NL | LGZ |
| May 31, 2024 | K232107 | °M Warmer System Mequ A/S, DK | LGZ |
| Jun 5, 2023 | K211618 | Fluido Compact Blood and Fluid Warming System The Surgical Company International B.V., NL | LGZ |
| Dec 8, 2022 | K211800 | Warrior Blood and Fluid Warmer, Warrior EXTREME Blood and Fluid Warmer, Warrior Lite Blood and Fluid Warmer Quality IN Flow , Ltd., IL | LGZ |
| Aug 12, 2022 | K202461 | ThermaCor 1200 Disposable Sets for the ThermaCor 1200 Rapid Thermal Infusion System Smisson-Cartledge Biomedical, LLC | LGZ |
| May 24, 2022 | K213191 | S-Line Barkey GmbH & Co. KG, DE | LGZ |
| Oct 18, 2019 | K192325 | Quantum Blood and Fluid Warming System Life Warmer, Inc. | LGZ |
| Mar 5, 2019 | K180842 | MAC Medical D-Series Blanket and Solution Warming Cabinets Mac Medical, Inc. | LGZ |
| Jan 28, 2019 | K181775 | Quantum Blood and IV Fluid Infusion Warmer Life Warmer, Inc. | LGZ |
| Apr 27, 2018 | K180154 | QiF Blood and Fluid Warmer Quality IN Flow , Ltd., IL | LGZ |
| Sep 27, 2017 | K171215 | QiF Blood and Fluid Warmer Quality IN Flow , Ltd., IL | LGZ |
| Apr 20, 2017 | K163708 | QiF Blood and Fluid Warmer Quality IN Flow , Ltd., IL | LGZ |
| Dec 28, 2016 | K161613 | Hang&Go PAC Rand S.R.L., IT | LGZ |
| Jun 23, 2016 | K150404 | QiF Blood and Fluid Warmer Quality IN Flow , Ltd., IL | LGZ |
| Sep 2, 2015 | K152208 | The Belmont Hyperthermia Pump Belmont Instrument Corporation | LGZ |
| Jul 9, 2015 | K150484 | Penguin In-Line Warmer Creche Innovations | LGZ |
| Dec 6, 2013 | K132202 | DC SERIES FLUID WARMING CABINET, DC SERIES FLUID WARMING CABINET Enthermics Medical Systems, Inc. | LGZ |
| Nov 6, 2013 | K131519 | BELMONT HYPERTHERMIA PUMP Belmont Instrument Corp. | LGZ |
| Oct 3, 2013 | K132110 | NATUS WARMETTE BLANKET AND DUAL CABINETS Natus Nicolet Ireland, Ltd., IE | LGZ |
| Jun 14, 2013 | K130867 | ENFLOW IV FLUID WARMER INSULATED STRAP Vital Signs, Inc., A GE Healthcare Company | LGZ |
| Jun 13, 2013 | K122449 | ENTERAL NUTRITION WARMER Acacia, Inc. | LGZ |
| Nov 28, 2012 | K121775 | ENFLOW IV FLUID WARMER, ENFLOW DISPOSABLE CARTRIDGE, ENFLOW CONTROLLER Vital Signs, Inc., A GE Healthcare Company | LGZ |
| Jul 12, 2012 | K121198 | BW685, BW685S Biegler GmbH | LGZ |
| May 8, 2012 | K120860 | INFU BOX TYPE 0412A Medical Rescue Equipment Holding AS, NO | LGZ |
| May 8, 2012 | K120026 | PERFORMER HT/ HANG&GO HT BASIC Rand S.R.L., IT | LGZ |
| Mar 29, 2012 | K112702 | IMPERIAL SURGICAL LTD. BLANKEY AND SOLUTION WARNING CABINETS Imperial Surgical , Ltd., CA | LGZ |
| Mar 21, 2012 | K102900 | HEITER 3000 HYPERTHERMIC PERFUSION SYSTEM Hei, Inc. | LGZ |
| Mar 14, 2012 | K112902 | ENFLOW IV FLUID WARMER Vital Signs, Inc. | LGZ |
| Jul 29, 2011 | K111870 | AMSCO WARMING CABINET STERIS Corporation | LGZ |
| Jun 3, 2011 | K110769 | AMSCO WARMING CABINET STERIS Corporation | LGZ |
| May 20, 2011 | K103801 | HYPOTHERMX INTRAVENOUS FLUID WARMER Emit Corporation | LGZ |
| May 7, 2010 | K091336 | IVNOW MODULAR FLUID WARMER, 120V, MODEL IVNOW-1, IVNOW-2, IVNOW-3, IVNOW-6, IVNOW MODULAR FLUID WARMER 230V Enthermics Medical Systems, Inc. | LGZ |
| Mar 4, 2010 | K092366 | TTS100 PORTABLE HYPERTHERMIC PERFUSION DEVICE Thermal Therapeutic Systems, Inc. | LGZ |
| Dec 18, 2009 | K092823 | AMSCO WARMING CABINET STERIS Corporation | LGZ |
| Feb 12, 2009 | K090089 | BELMONT HYPERTHERMIA PUMP Belmont Instrument Corp. | LGZ |
| Dec 18, 2008 | K082765 | ASTOFLO PLUS Stihler Electronic GmbH | LGZ |
| Oct 6, 2008 | K082217 | RANGER RAPID FLOW BLOOD/FLUID WARMING SYSTEM Arizant Healthcare, Inc. | LGZ |
| Jun 2, 2008 | K072080 | NORMOFLO IRRIGATION FLUID WARMER, MODELS H-1100, H-1129, NORMOFLO IRRIGATION WARMING SET, MODELS, IR-40, IR-500, IR-600, Smiths Medical Asd, Inc. | LGZ |
| Mar 20, 2008 | K073363 | THERMOSTAT 900 ADMINISTRATION SET, MODEL ASH 100, 200 AND 300 Paladin Biomedical Corporation | LGZ |
| Sep 11, 2007 | K062644 | FLEXWARMER, MODELS KZ-1 AND KZ-2 Merlyn Associates, Inc. | LGZ |
| Jun 8, 2007 | K070654 | HYPERTHERMIA PUMP Belmont Instrument Corp. | LGZ |
| Dec 22, 2006 | K060851 | SOFT SACK IV FLUID WARMER, THE FLOORMOUNT IV FLUID WARMER, THE PAK 2 IV WARMER AND THE THERMAL SAC PRESSURE INFUSER The Smithworks Company | LGZ |
| Oct 26, 2006 | K052055 | SMISSON-CARTLEDGE THERMAL INFUSION SYSTEM, MODEL TIS-1200 Smisson-Cartledge Biomedical, LLC | LGZ |
| Jun 26, 2006 | K060939 | RANGER IRRIGATION FLUID WARMING SYSTEM Arizant Healthcare, Inc. | LGZ |
| Jun 8, 2006 | K060537 | EFLOW IV FLUID WARMER, MODEL 100, EFLOW DISPOSABLE CARTRIDGE, MODEL 200 AND EFLOW AC POWER SUPPLY, MODEL 120 Enginivity, LLC | LGZ |
| Feb 15, 2005 | K041839 | 8NONE Medical Solutions, Inc. | LGZ |
| Sep 22, 2003 | K032778 | LARGE VOLUME FLUID RESERVOIR Belmont Instrument Corp. | LGZ |
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