BEUDAMED
    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: LZG FDA class 2

    Pump, Infusion, Insulin

    General Hospital

    View full classification →

    The Insulin Infusion Pump (product code LZG) is a programmable medical device that delivers precise subcutaneous doses of insulin continuously and on-demand to patients with diabetes, replicating the function of the pancreas in regulating blood glucose levels. Regulated under 21 CFR 880.5725 and classified as a Class 2 device, it requires a 510(k) premarket notification and falls under the General Hospital specialty with review by the Chemistry (CH) panel. It is not flagged as an implant or life-sustaining device.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Modular Medical MODD1 Insulin Delivery System
    Extended Reservoir; MiniMed Reservoir
    Omnipod GO Insulin Delivery Device
    Extended Reservoir
    Omnipod® Insulin Management System, Omnipod DASH® Insulin Management System
    Omnipod Insulin Management System, Omnipod DASH Insulin Management System
    Omnipod Insulin Management System, Omnipod DASH Insulin Management System
    Omnipod DASH Insulin Management System
    OmniPod Insulin Management System
    t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater
    t:slim Insulin Delivery System
    t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater
    OmniPod Insulin Management System
    t:flex Insulin Delivery System
    Snap Insulin Pump System
    OMNIPOD INSULIN MANAGEMENT SYSTEM
    T:SLIM INSULIN DELIVERY SYSTEM
    T:SLIM INSULIN DELIVERY SYSTEM
    OMNIPOD INSULIN MANAGEMENT SYSTEM
    PEARL DIABETES MANAGEMENT SYSTEM
    OMNIPOD INSULIN MANAGMENT SYSTEM
    ACCU-CHECK COMBO SYSTEM
    MEDTRONIC MINIMED PARADIGM INSULIN PUMPS
    FREESTYLE GLUCOSE METER INCORPORATED INTO THE OMNIPOD INSULIN MANAGEMENT SYSTEMS
    T:SLIM (TM) INSULIN DELIVERY SYSTEM
    PEARL DIABETES MANAGEMENT SYSTEM
    V-GO INSULIN DELIVERY SYSTEM
    V-GO DISPOSABLE INSULIN DELIVERY DEVICE, MODEL# V-GO 20, V-GO 30, V-GO40
    SOLO MICROPUMP INSULIN DELIVERY SYSTEM
    SOLO INSULIN PATCH PUMP
    FREESTYLE AVIATOR INSULIN DELIVERY AND BLOOD GLUCOSE MONITORING SYSTEM
    SYMPHONY METER REMOTE
    MODIFICATION TO:ACCU-CHEK POCKET COMPASS DIABETES MANAGEMENT SOFTWARE
    SYMPHONY GLUCOSE MANAGEMENT SYSTEM
    NILIMEDIX ADI
    PARADIGM INSULIN INFUSION PUMP, MODELS MMT-512, MMT-712, MMT-515 AND MMT-715
    AVIATOR INSULIN PUMP
    AMIGO INSULIN PUMP
    EZMANAGER MAX DIABETES MANAGEMENT SOFTWARE
    DANA DIABECARE IIS
    DELTEC COZMO INSULIN INFUSION PUMP WITH COZMONITOR BLOOD GLUCOSE METER, MODELS 21-1815, 21-1816, 21-1817
    ACCU-CHEK INSULIN PUMP CONFIGURATION SOFTWARE (STANDARD), MODEL 04625137001; ACCU-CHEK INSULIN PUMP CONFIGURATION SOFTWA
    MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODEL MMT-712E
    INSULIN PUMP
    ACCU-CHEK POCKET COMPASS DIABETES MANAGEMENT SOFTWARE
    BIOVALVE INSULIN DELIVERY SYSTEMS (BIDS)
    AMIGO INSULIN PUMP
    ACCU-CHEK SPIRIT
    IXL-II DIABETES MANAGEMENT SYSTEM
    ANIMAS MODEL IR1250 INSULIN INFUSION PUMP

    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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