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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: LHI FDA class 2

    Set, I.V. Fluid Transfer

    General Hospital

    View full classification →

    An I.V. fluid transfer set is a tubing and connector assembly used in hospital settings to transfer intravenous fluids from one container to another or to prepare IV admixtures, facilitating safe and sterile fluid management during patient care. The device is FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance. It carries product code LHI and is regulated under 21 CFR 880.5440 within the General Hospital specialty. This device is eligible for third-party review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    ADRx™ Admixture Device
    Vial Adapter
    Medline Bag Decanter
    FlowArt® Vial Access Device Vented
    Medline Microtek C-Flo Bag Decanter, Sterile (2000S); Medline Microtek Bag Decanter II, Sterile (2002S); Medline Microtek Vial Decanter, Sterile (2006S); Medline Microtek Transfer Device, Sterile (2008S)
    HyHub™ and HyHub™ Duo Vial Access Devices
    Arisure® Closed Male Luer with Spike Adapter (YM060)
    Rio™ Drug Reconstitution Transfer Device
    SmartSiteTM Vented Vial Access Device
    nextaro® va, 15mm, 5µm
    Vent Vial Adapter
    FlowArt Valve for Vial Access
    Vial2Bag Advanced® 20mm Admixture Device
    Vial Adapter with Filter
    nextaro® v, 20/20
    BD SmartSite™ 13mm Vial Access Device; BD SmartSite™ 20mm Vial Access Device
    Mix2Vial® Transfer Device
    Vial Adapter 20mm
    Vial2Bag Advanced® 13mm Admixture Device
    Vial Adapter
    MixJect® Transfer Device
    Vial Adapter
    Vented Vial Adapter 20mm
    Advcare Vial Direct to Bag (VDB) Needle-free Admixture Devices
    Vial Adapter Ø13mm
    freeflex+ Transfer Adapter
    IVX Fluid Transfer Set
    SOL-CARE IV Bag Safety Connector
    B Dispensing Line
    ProntoPump Sterile Tube Set
    Mini Spike Plus 6/8R
    Vial2Bag Advanced 20mm Admixture Device
    Rio Vial-to-Bag Drug Reconstitution Device
    Decanting Device
    Vial Adapter Ø20 mm , Vial Adapter Ø13 mm
    Vial Adapter Ø20 mm
    nextaro Transfer System, nextaro va
    Guarded Luer Connector
    GRI-FILL PERISTALTIC SET
    Vial Adapter 15mm
    Arisure Closed Vial Adapter
    Arisure Dry Spike
    Vial2Bag Direct Connect
    OnSite-IV
    Vented Vial Adapter Transfer Device - 13mm
    APEX Compounding System Transfer Set
    KIRO Set
    Universal Spike
    SmartSite Vented Vial Access Device
    VIAL-MATE Adaptor

    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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