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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: FPA FDA class 2

    Set, Administration, Intravascular

    General Hospital

    View full classification →

    The Intravascular Administration Set is a complete assembly of tubing and fittings used to deliver intravenous fluids, blood products, or medications from a container into a patient's bloodstream through an intravascular catheter. It is classified as FDA Class 2 (moderate risk) and requires 510(k) premarket notification. The product code is FPA, regulated under 21 CFR 880.5440 in the General Hospital specialty. This device is eligible for third-party review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    iiSure Infusion Set
    AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)
    PuraCath Firefly Needleless Connector IT (9005)
    nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727]
    BD Alaris Pump Infusion Set
    EZ™ IV Administration Set
    SteadiSet infusion set
    Sparta Infusion Set for Insulin
    Infusomat® Space Volumetric Infusion Pump Administration Sets
    Clave™ Neutral-Displacement Needlefree Connectors
    SteadiSet Infusion Set
    JetCan® Pro Safety Huber Needle
    Solution Administration Sets
    Intravascular Extension Sets and Accessories
    Lyka® PORT Needle Free Access Device (4170Y)
    Ecomed Disposable Administration Sets
    I.V. Administration Set
    Disposable infusion set with needle
    Disposable Extension Set
    Insignis™ Syringe Infusion System
    ResQ Administration Set
    Extension Set
    LILY Extension Tube and Needleless Connector
    ProSeal™ Closed System Administration Set
    BD Alaris™ Pump Infusion Sets
    Surflo Winged Infusion Set
    Volumat Polyethylene I.V. Administration Set
    DJF Intravascular Administration Set
    Volumat Line
    I.V. Administration Set, I.V. Extension Set
    BD Secondary Infusion Set
    NP Medical nPulse K150 Neutral Displacement Needle Free Connector, nPulse Neutral displacement needle free connector, nPulse K150 Needle Free Connector
    Polyfusion IV Administration Sets
    BD SmartSite™ Needle-Free Connector
    FlowArt® Needle-Free Split Septum Valve
    Infusion Sets for Single Use
    Infusion Sets for Single Use with Needles
    Intravenous Needles for Single Use,Safety Intravenous Needles for Single Use
    NP Medical nCompass Extension Set with Stabilizing Base
    AMSafe NeuFlo Needleless Connector
    PCA Syringe Sets
    Flowart
    NeutrArt
    Q2 Blood Administration Sets
    Q2 IV Administration Sets
    Needle Free Connector
    Infusion Sets for Single Use
    IV Administration Set
    Microvolume Luer Access Device
    Ivenix Infusion System, LVP Epidural Administraion Set NRFit Connector

    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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