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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: KDI FDA class 2

    Dialyzer, High Permeability With Or Without Sealed Dialysate System

    Gastroenterology, Urology

    View full classification →

    A high-permeability dialyzer, with or without a sealed dialysate system, is a kidney replacement therapy device that filters blood through a semipermeable membrane to remove uremic toxins, excess fluid, and electrolytes in patients with acute or chronic renal failure, using high-flux membranes for enhanced clearance of middle and large molecular weight solutes. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket clearance. Product code KDI is regulated under 21 CFR 876.5860 in the Gastroenterology, Urology medical specialty. This device is designated as life-sustaining or life-supporting, reflecting its critical role in maintaining patient survival.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    2008T HD SYS. CDX BLUESTAR (191124); 2008T HD SYS. CDX W/bibag BLUESTAR (191126); 2008T HD SYS. W/O CDX BLUESTAR (191128); 2008T HD SYS. W/O CDX W/bibag BLUESTAR (191130)
    5008X Hemodialysis System
    DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO)
    DHF 0.2 Hemoconcentrator (DHF 02); DHF 0.6 Hemoconcentrator (DHF 06); SH 14 Hemoconcentrator (SH 14)
    FX CorAL 40 (F00009214); FX CorAL 50 (F00009215)
    FX CorAL 60 (F00012969); FX CorAL 80 (F00012970); FX CorAL 100 (F00012971); FX CorAL 120 (F00012972); FX CorAL 600 (F00012973); FX CorAL 800 (F00012974); FX CorAL 1000 (F00012975)
    Moda-flx Hemodialysis System and Cartridge
    HemoCare Hemodialysis System
    multiFlux 1000 (F00012408)
    Tablo® Hemodialysis System; TabloCart™ with Prefiltration Drawer
    NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E)
    Purema® H Hemoconcentrator (EtO Sterilized)
    5008X Hemodialysis System
    2008T BlueStar Hemodialysis Machine
    Tablo® Hemodialysis System
    CleanCart A, CleanCart C, AK 98 Hemodialysis Machine
    VersiHD with GuideMe software
    Tablo® Hemodialysis System
    ClearumTM HS
    FX CorAL 60, FX CorAL 80, FX CorAL 100, FX CorAL 120, FX CorAL 600, FX CorAL 800, FX CorAL 1000
    multiFiltratePRO System
    SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube Set
    2008T BlueStar Hemodailysis Machine
    Tablo Hemodialysis System
    HDF Assist Mudule, HDF Infusion Set and Substitution Filter
    Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 set
    Revaclear 500, Revaclear 400, Revaclear 300
    SC+ Hemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tubeset
    AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber Accessory
    Optiflux Series of Dialyzers F160NR, F180NR, F200NR
    SC+ Haemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tube Set
    Clearum HS Family, Clearum HS Models: HS 13, HS 15, HS 17, HS 20, HS 22
    Optiflux F180NR Dialyzer
    DIMI RRT System
    Optiflux Enexa F500 Dialyzer
    Tablo Hemodialysis System
    PrisMax System Version 3
    Aquadex FlexFlow System 2.0
    Tablo Hemodialysis System, Tablo Cartridge
    NxStage Cartridge Express with Speedswap
    PrisMax System Version 2
    Surdial DX Hemodialysis System
    2008T BlueStar Hemodialysis Machine
    Prismaflex System 8.10
    SAM CRRT Unit, SAM Cassette CRRT
    NxStage System One
    Diacap Pro Dialyzer
    NxStage System One Plus
    Asahi ViE-U Series Dialyzer
    PrisMax Control Unit

    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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