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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: FPK FDA class 2

    Tubing, Fluid Delivery

    General Hospital

    View full classification →

    The Fluid Delivery Tubing is a length of flexible tubing used within IV administration sets or medical fluid circuits to convey liquids from a source container to the patient or to a connecting device. It is classified as FDA Class 2 (moderate risk) and requires 510(k) premarket notification. The product code is FPK, 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
    MEDRAD TWIST & GO HIGH PRESSURE CONNECTOR TUBING
    DISPOSABLE TRANSFER SETS WITH AND WITHOUT SWABBABLE VALVES AND/OR CHECK VALVES
    LIFESHIELD LATEX-FREE GRAVITECH FLOW CONTROLLER I.V. SETS, MODELS 17528, 17527, 17525 & 17526
    MEDTRONIC MINIMED LEAPFROG II INFUSION SET, MODELS MMT-801S1, MMT-801L1, MMT-801S2, MMT-801L2, MMT-803S1
    EMPOWER TRANSFER SET, (CAT. NO. 7725)
    MEDRAD SWABBABLE VALVE TRANSFER SET
    MEDRAD TRANSFER SET
    POLYFIN EXTENSION SET, MODELS 126 AND 128
    SILCLEAR TUBING (MODIFICATION)
    SYSMEX SF-3000
    EXTENSION SET/I.V. SET
    60 MICRO VOLUME EXTENSION SET W/.22 MICRON FILTER, 21 EXTENSION SET W/1.2 MIVTON GILYRT, INJ. SITE, CLAMP
    RECONSTITUTION ACCESSOREIS
    EXTENTION SET
    IVID
    SILCLEAR TUBING
    VARIOUS TUBING
    INTRAVASCULAR ADMINISTRATION SET
    LIFESHIELD EXTENSION SET
    EVANS MEDICAL EXTENSION SETS
    NON-INVASIVE TUBING
    OPHTHALMIC FLUID DISTRIBUTION SETS
    LO-PROFILE EXTENSION SET
    LIFESHIELD EXTENSION SET
    CENTURION KLEEN-NEEDLE SYSTEM I.V. EXTENSION SETS
    INTRAVASCULAR ADMINISTRATION SET MODEL 60040
    INTRAVASCULAR ADMINI. SET MODELS 60030 & 60050
    MERIT HI-FLEX(TM)
    HYPERBARIC INTRAVENOUS INFUSION EXTENSION SET
    CMS IV EXTENSION SETS
    IV EXTENSION SET
    VAN DELLEN BACTERIA FILTER
    INFUSION MANIFOLD
    PLASTIC TUBING CONNECTOR
    EXTENSION TUBE PUMP SET
    SWIVEL CONNECTORS #014452/#014453/#014459-120
    LP EXTENSION SETS
    T-CONNECTORS 014500/014501/014502/014503-120
    VARIOUS LUER AND TUBING FITTINGS
    EXTENSION SETS
    LOW VOLUME EXTENSION SET
    CHURCHILL EXTENSION TUBE
    CHURCHILL-H EXTENSION TUBE
    SPINAL NEEDLES & ACCESSORY
    IV EXTENSION SET
    C-FLEX MEDICAL GRADE TUBING
    RED COLOR-TINTED TUBING
    ANESTHESIA EXTENSION TUBES
    FLUVEN SETS (EXT-1, EXT-2, EXT-3, EXT-4)
    SEA MEDICAL PRODUCTS LO-VOL

    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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