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    Tool · 510(k)

    510(k) Predicate Finder

    Find potential predicate devices for your 510(k) submission. Enter a K-number to find all clearances with the same product code, a three-letter product code to browse clearances directly, or search by device name.

    Product Code: LGZ FDA class 2

    Warmer, Thermal, Infusion Fluid

    General Hospital

    View full classification →

    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.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    °M Warmer System
    Fluido Compact Blood and Fluid Warming System
    Warrior Blood and Fluid Warmer, Warrior EXTREME Blood and Fluid Warmer, Warrior Lite Blood and Fluid Warmer
    ThermaCor 1200 Disposable Sets for the ThermaCor 1200 Rapid Thermal Infusion System
    S-Line
    Quantum Blood and Fluid Warming System
    MAC Medical D-Series Blanket and Solution Warming Cabinets
    Quantum Blood and IV Fluid Infusion Warmer
    QiF Blood and Fluid Warmer
    QiF Blood and Fluid Warmer
    QiF Blood and Fluid Warmer
    Hang&Go PAC
    QiF Blood and Fluid Warmer
    The Belmont Hyperthermia Pump
    Penguin In-Line Warmer
    DC SERIES FLUID WARMING CABINET, DC SERIES FLUID WARMING CABINET
    BELMONT HYPERTHERMIA PUMP
    NATUS WARMETTE BLANKET AND DUAL CABINETS
    ENFLOW IV FLUID WARMER INSULATED STRAP
    ENTERAL NUTRITION WARMER
    ENFLOW IV FLUID WARMER, ENFLOW DISPOSABLE CARTRIDGE, ENFLOW CONTROLLER
    BW685, BW685S
    INFU BOX TYPE 0412A
    PERFORMER HT/ HANG&GO HT BASIC
    IMPERIAL SURGICAL LTD. BLANKEY AND SOLUTION WARNING CABINETS
    HEITER 3000 HYPERTHERMIC PERFUSION SYSTEM
    ENFLOW IV FLUID WARMER
    AMSCO WARMING CABINET
    AMSCO WARMING CABINET
    HYPOTHERMX INTRAVENOUS FLUID WARMER
    IVNOW MODULAR FLUID WARMER, 120V, MODEL IVNOW-1, IVNOW-2, IVNOW-3, IVNOW-6, IVNOW MODULAR FLUID WARMER 230V
    TTS100 PORTABLE HYPERTHERMIC PERFUSION DEVICE
    AMSCO WARMING CABINET
    BELMONT HYPERTHERMIA PUMP
    ASTOFLO PLUS
    RANGER RAPID FLOW BLOOD/FLUID WARMING SYSTEM
    NORMOFLO IRRIGATION FLUID WARMER, MODELS H-1100, H-1129, NORMOFLO IRRIGATION WARMING SET, MODELS, IR-40, IR-500, IR-600,
    THERMOSTAT 900 ADMINISTRATION SET, MODEL ASH 100, 200 AND 300
    FLEXWARMER, MODELS KZ-1 AND KZ-2
    HYPERTHERMIA PUMP
    SOFT SACK IV FLUID WARMER, THE FLOORMOUNT IV FLUID WARMER, THE PAK 2 IV WARMER AND THE THERMAL SAC PRESSURE INFUSER
    SMISSON-CARTLEDGE THERMAL INFUSION SYSTEM, MODEL TIS-1200
    RANGER IRRIGATION FLUID WARMING SYSTEM
    EFLOW IV FLUID WARMER, MODEL 100, EFLOW DISPOSABLE CARTRIDGE, MODEL 200 AND EFLOW AC POWER SUPPLY, MODEL 120
    8NONE
    LARGE VOLUME FLUID RESERVOIR
    BELMONT FLUID MANAGEMENT SYSTEM, MODEL FMS2000
    MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODEL MMT-712
    MODIFICATION TO ANIMEC, MODELS AM-2S-4, AM-2S-5, LT-1-4 & LT-1-5
    MAXONE IV FLUID/BLOOD WARMER, MODEL 102

    What is a Predicate Device?

    A predicate device is a legally marketed device that a new 510(k) applicant uses to demonstrate substantial equivalence. The FDA's 510(k) pathway requires manufacturers to show that their device has the same intended use and similar technological characteristics as one or more predicate devices already cleared for commercial distribution.

    Finding the right predicate is a critical step in 510(k) strategy. Manufacturers typically search for cleared devices with the same FDA product code, which groups devices by their intended use and regulatory classification. This tool helps you identify potential predicates by browsing all clearances within a product code.

    Note that predicate devices must be legally marketed — they cannot be devices that were cleared but never commercialized, or devices subject to a mandatory recall. The determination of substantial equivalence considers intended use, technological characteristics, and performance data.

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