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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: FJI FDA class 2

    Dialyzer, Capillary, Hollow Fiber

    Gastroenterology, Urology

    View full classification →

    The Capillary Hollow Fiber Dialyzer is a hemodialysis device in which blood flows through thousands of hollow semipermeable fibers arranged in a bundle, while dialysate flows in the opposite direction around the fibers, enabling efficient solute clearance and fluid removal. It is classified as FDA Class 2, requiring 510(k) premarket clearance, and is considered life-sustaining or life-supporting. The product code is FJI, regulated under 21 CFR 876.5820, within the Gastroenterology, Urology specialty.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Hemoflow F3 and F4 Dialyzers
    NIPRO PUREFLUX-L HEMODIALYZER
    POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND MULTIPLE USE, MODELS 14L, 17L, 21L, 140H, 170H, 210H,6LR, 8LR
    DISPOSABLE STORAGE CAP
    ULTRACONCENTRATOR SYSTEM
    FRESNIUS HEMOFLOW F7NR, F50NR, F70NR HEMODIALYZERS
    IDEMSA HEMOPHAN HOLLOW FIBER DIALYZERS
    A-15 HEMODIALYZER
    A-18 HEMODIALYZER
    ASAHI AM-R-SERIES DIALYZERS (MODIFIED), MODEL AM-NR-X
    DYNAMIC HOLLOW FIBER DIALYZER DH-SERIES, MODEL AH 90111
    CUPROPHAN AND HEMOPHAN HOLLOW FIBER DIALYZER
    ULTRACON ULTRAFILTRATOR
    PSN DIALYZER, MODEL PSN 130/R5M4233, MODEL PSN-150/R5M4234
    ULTRACON ULTRAFILTRATOR
    CLIRANS T-SERIES HOLLOW FIBER DIALYZERS
    DYNAMIC HOLLOW FIBER DIALYZER DC-SERIES
    PSN-120 HOLLOW FIBER DIALYZER AND PSN-140 HOLLOW FIBER DIALYZER
    ALTERNATE ENCAPSULATING RESIN SYSTEM FOR MCA HEMODIALYZERS
    BLLOD PORT CAP, DIALYSATE PORT CAP, VENTED DIALYSATE PORT CAP WITH RED PLIABLE VINYL
    BLOOD PORT CAP, DIALYSATE PORT CAP, RED HARD PLASTIC
    BLOOD PORT CAP, LUER-LOCK FITTING, DAYSPRING MEDICAL PART NO. BPC252LL
    COBE CENTRYSYSTEM CS 200 DIALYZER
    FOCUA 90R, 90HR, 120R, 120HR, 160R, 160HR HOLLOW FIBER DIALYZER
    PORT CAPS (PROTECTIVE CLOSURES FOE REPROCESSED HEMODIALYZERS
    GAMBRO LUNDIA 94-500 DIALYZER
    MCA(TM) 180 HEMODIALYZER
    FILTRYZER(TM)
    MCA(TM) 130 HEMODIALYZER
    MCA(TM) 160 HEMODIALYZER
    155 SCE(TM) HEMODIALYZER
    COBE CENTRYSYSTEM CS500 DIALYZER
    FILTRYZER
    CAHP HIGH PERFORMANCE CELLULOSE DIACETATE HOLLOW FIBER DIALYZER
    CLIRANS WET PACK HOLLOW FIBER DIALYZER
    MCA 200 HEMPDIALYZER
    BAXTER CA DIALYZER
    FRESENIUS HEMOFLOW, VARIOUS MODELS
    HOLLOW FIBER DIALYZER FOCUS 9OR/90H-R/120R/120H-R
    ALDETECT
    NEW COBE CENTRYSYSTEM(TM) 100 HG DIALYZER
    MODEL CA.150 CELLULOSE ACETATE HOLLOW FIBER DIALYZ
    BIO* NEPHROSS ANDANTE, MODERATO, ALLEGIO H.F.
    GAMBRO ALWALL GFS PLUS 11, 16 & 20 HOLLOW FIBER
    HOLLOW FIBER DIALYZER FOCUS 70H
    CLIRANS HOLLOW FIBER HEMODIALYZER (WET)
    NEW AM-SERIES DIALYZERS
    MODIFIED AM-SERIES DIALYZERS
    GAMBRO ALWALL GFS 11,12,PLUS 12 HOLLOW FIBER DIALY
    TORAY FILTRYZER DIALYZERS

    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.

    Popular Product Codes

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