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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: FPB FDA class 2

    Filter, Infusion Line

    General Hospital

    View full classification →

    The Infusion Line Filter is a component installed in an intravenous administration set to remove particulates, microorganisms, or air bubbles from fluids before they enter the patient's bloodstream. It is classified as FDA Class 2 (moderate risk) and requires 510(k) premarket notification. The product code is FPB, 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
    Filter Needle for Single Use
    Cathivex ¿GV filter units
    NON-DEHP MICRO-VOLUME EXTENSION SET WITH 0.22 MICRON FILTER
    ARTERIA BLOOD FILTER
    PALL SUPOR AEF FILTER
    0.2 U BACTERIAL FILTER
    AUTOPRIME
    PALL LEA FILTER (LIPID EMULSION FILTER) (I.V. FILTER)
    I.V. FILTER SET
    40 MICRON BLOOD TRANSFUSION FILTER
    1.2 MICRON AIR ELIMINATING FILTER
    PHARMASSURE LARGE VOLUME TRANSFER FILTERS
    2 MICRON AIR ELIMINATING FILTER
    IVEX-2 EXTENSION SET WITH Y-INJECTION SITE
    VIAL VENT FILTER
    CHARGED SUPOR(R) FILTER EXTENSION SET
    EXTENSION SET WITH 0.22 MICRON 96 HOUR FILTER
    1.2 MICRON FINAL FILTER WITH EXTENSION TUBE
    MIS CLEAN-SET FLUSHING UNIT AND ACCESSORIES
    0.2. MICRON FILTER SETS AND 1.2 MICRON FILTER SETS
    FENWAL(R) 40/150 MICRON DUAL SCREEN FILTER
    FENWAL 40 MICRON TRANSFUSION FILTER
    IVEX-HP96 EXTENDED LIFE FILTER SET
    IVEX-TPN EXTENSION FILTER SET
    I.V. FILTER EXTENSION SET
    PALL 3N1 FILTER
    I.V. EXTENDER SET
    CMS IV FILTERS
    1.2 MICRON FILTER WITH IV SET
    .22 & 1.2 MICRON IV FILTERS
    LABELING CHANGE FOR CUTTER PUREFLO PLUS IV FILTER
    CHURCHILL 0.22 MICRON LIQUID FILTER SETS
    CHURCHILL 0.22 MICRON LIQUID COMPACT FILTER SETS
    CHURCHILL 1.2 MICRON LIQUID FILTER SET
    CUTTER PUREFLO PLUS IV FILTER
    CONTINU-FLO SOLUTION ADMIN. SET W/IN-LINE FILTER
    CLYDE (TM) FILTRATION SYSTEM
    CRITIKON 48-HOUR AIR ELIMINATING FILTER
    FAST FLOW XX (AQUEOUS SOLUTION FILTER)
    IV FILTER EXTENSION SET
    AUTO SYRINGE MICRO VOL EXT SET W/AIR VENT FILTER
    PREVENT 0.2 MICRON IV FILTER W/VENT & EXTENSION SE
    I.V. WATCH
    DYNA GARD SYRINGE FILTER
    SARTORIUS MINI SART FH 16592
    SARTORIUS MINISART FH 16534
    SARTORIUS MINI-SART FH 16555
    I.V. WATCH
    PEDIATRIC IV WATCH
    AEF POSIDYNE I.V. FILTER/AIR ELIMINATOR

    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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