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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: LDR FDA class 2

    Controller, Infusion, Intravascular, Electronic

    General Hospital

    View full classification →

    An electronic intravascular infusion controller is a general hospital device that uses electronic control mechanisms to regulate the flow rate of intravenous fluids administered to patients, providing more precise delivery than gravity-based systems. It is classified as FDA Class 2, reflecting moderate risk and requiring 510(k) premarket clearance. The product code is LDR, regulated under 21 CFR 880.5725, in the General Hospital specialty. No special risk flags apply.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    DEKA Infusion System, DEKA Administration Set
    DEKA Infusion System, DEKA Administration Set
    Volumetric Infusion Controller
    PACER MODEL 100 INFUSION CONTROLLER
    ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M12/500-3P
    ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M12/500
    UNIVERSAL CONTROLLER, MODEL 100
    FLOW CONTROLLING EXTENSION SET
    STAT 2 IV PUMPETTE
    MASTER FLOW I.V. PUMPETTE
    3M IV FLOW REGULATOR
    VARI-SET
    IVAC(R) VOLUMETRIC CONTROLLER - MODEL 262+
    LIFECARE 75 CONTROLLER
    IVAC(R) VOLUMETRIC CONTROLLER - MODEL 262
    IVY COMMANDER, MODEL 600
    STA-SET I.V. FLOW REGULATOR
    TECHNICON CHEM 1(TM) SYSTEM
    IVAC(R) VOLUMETRIC CONTROLLER - MODEL 290
    IVAC(R) SITE-SAVER(R) VOLUMETRIC CONTROLLER - 280+
    IVY COMMANDER (MODEL 500)
    IVAC (R) SITE-SAVER (TM) VOLUMETRIC CONTROLLER 280
    IVAC FLOW CONTROL ADMINISTRATION SET
    BETAFLO 2000 PIGGYBACK SYSTEM
    STA-SET MODEL 250 I.V. FLOW REGULATOR
    DEKA JR.
    BETAFLO 2000
    FLO-GARD 4000 VOLUMETRIC INFUSION CONTROLLER
    RATEMINDER III INFUSION DEVICE
    DOSI FLOW
    ARM-A-FLOW INTRAVENOUS FLOW REGULATOR
    DK*300 VOLUMETRIC INFUSION CONTROLLER
    IVAC 280 VOLUMETRIC INFUSION CONTROLLER
    IVENT 302VC DUAL CONTROLLER
    A.S.A.P.
    ABBOTT LIFECARE 1050 CONTROLLER
    INTRAVENOUS INFUSION CONTROLLER
    IVY COMMANDEER
    FLO-GARD 4000 VOLUMETRIC INFUSION
    TREONIC C30
    MODEL 2001 INTELLIGENT INFUSOR
    FLO-GARD 8000 COMPUTER CONTROL INFUSI
    ELECTRONIC GRAVITY 300VC
    RATEMINDER II SPECIALTY CARE
    STEDIFLO INFUSION SET
    PRIMARY PIGGYBACK INFUSION SET W/PERM
    POCKET AID
    KOALA C99 I.V. CONTROLLER
    VOLUMERIC CONTROLLER
    FLO CONTROL

    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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