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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: KDN FDA class 2

    System, Perfusion, Kidney

    Gastroenterology, Urology

    View full classification →

    A kidney perfusion system is a device used to mechanically circulate a preservation solution through the vasculature of a harvested donor kidney to maintain metabolic function, reduce cold ischemic injury, and potentially improve post-transplant outcomes. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket clearance. Product code KDN is regulated under 21 CFR 876.5880 in the Gastroenterology, Urology medical specialty. This device is eligible for third-party review under FDA's accredited persons program.

    510(k) Clearances

    41 matches
    K Number
    Device Name
    EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250)
    X°Port Lung Preservation System; X°Port Lung Preservation Solution
    DCX Disposable Cassette (DCX)
    Belzer UW® Cold Storage Solution (BTLBUW-001)
    Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001)
    LungProtect
    KIDNEYvault Portable Renal Perfusion System
    Servator P Plus SALF Solution
    BAROguard
    KIDNEY ASSIST-transport
    RM4 Control Unit
    Servator P SALF Solution with THAM
    Cannula for Organ Perfusion
    SherpaPak Pediatric Liver Transport System
    SherpaPak Lung Preservation System , SherpaPak Liver Transport System
    Paragonix SherpaPak Pancreas Transport System
    EasiSlush
    Servator B SALF Solution
    Perfadex Plus
    Low Potassium Dextran Solution with Tris Diluent
    CoStorSol plus G
    Sherpa Pak Kidney Transport System
    SHERPA PAK TRANSPORTER
    WAVES
    PERFADEX AND PERFADEX WITH THAM
    COSTORSOL
    COSTORSOL
    MAPERSOL
    COSTORSOL
    RM3 RENAL PRESERVATION SYSTEM
    LIFEPORT, KIDNEY PERFUSION TRANSPORTER (KTR)
    MODIFICATION TO KPS-1, KIDNEY PERFUSION SOLUTIION
    KPS-I, THE KIDNEY PERFUSION SOLUTION
    CUSTODIOL
    HPA PORTABLE KIDNEY PRESERVATION SYSTEM, MODEL J-1000-1
    BELZER-MPS
    RM3 RENAL PRESERVATION SYSTEM--CONTROL UNIT
    K-SOL(TM)
    KIDNEY PERFUSION MACHINE
    KIDNEY TRANSPLANT CATHETER
    REDOX CONTROLLER

    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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