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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: LIF FDA class 2

    Dialyzer Reprocessing System

    Gastroenterology, Urology

    View full classification →

    A dialyzer reprocessing system is a device used in dialysis centers to clean, test, and prepare used hemodialysis filters (dialyzers) for reuse by individual patients, including rinsing, disinfecting, and verifying the integrity of the dialyzer membranes. The device is FDA Class 2, representing moderate risk and requiring 510(k) premarket clearance. It carries product code LIF and is regulated under 21 CFR 876.5820 within the Gastroenterology and Urology specialty. No special flags apply to this device.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    CLEARFLUX DIALYZER REPROCESSING SYSTEM
    ASSIST HEADER CLEANER
    STERICHEK GLUTARALDEHYDE REAGENT STRIPS
    RENACLEAN SH DIALYZER CLEANING SYSTEM
    MAKY 21.1 DIALYZER REPROCESSING SYSTEM
    ARM AUTOMATIC REPROCESSING MACHINE
    AMUKIN D
    RENACLEAR DIALYZER CLEANING SYSTEM
    POTENCY TEST STRIPS, INDICATOR TEST STRIPS
    STERICHEK(TM) RESIDUAL PEROXIDE REAGENT STRPS
    ALEXANDER MANUFACTURING RECHARGEABLE BATTERY (M1/T)
    DPS 4 DIALYZER PREPARATION SYSTEM
    DRS 4 DIALYZER REPROCESSING SYSTEM
    FORMALIN REUSE CART
    RENALIN REUSE CART
    DRS 4 ND DIALYZER REPROCESSING SYSTEM
    DIALYZER REPROCESSING SYSTEM
    DMS DATA MANAGEMENT SYSTEM/DRS-4 DIALYZER REPROCES
    SERIM RESIDUAL FORMALDEHYDE REAGENT STRIPS
    DRS-4 DIALYZER REPROCESSING SYSTEM
    SERIM FORMALDEHYDE REAGENT STRIPS (1.O% -2.0%)
    SERIM FORMALDEHYDE REAGENT STRIPS (2.5% -4.0%)
    FORMASURE TEST REAGENT
    SERIM GLUTARALDEHYDE/NEPHREX POTENCY TEST KIT
    RENATRON II DIALYZER REPROCESSING SYSTEM RS 8330
    SERIM RESIDUAL PEROXIDE/RENALIN TEST KIT
    TRANSLUMINAL ENDARTERECTOMY DEVICE
    FRESENIUS PURISTERIL 340 (TM)
    ADR-22 AUTOMATIC DIALYZER REPROCESSOR
    HR-3000 REUSE ADAPTOR
    MODIFIED HR-3000 REUSE ADAPTOR
    DRS-4 DIALYZER REPROCESSING SYSTEM
    ULTRAMAX III, DIALYZER REPROCESSING DEVICE
    COBE REN NEW-D DISPENSING KIT
    RENNEW-D SPORICIDE/DISINFECTANT FOR HEMODIALYZERS
    RINSE MACHINE KR-4 KIDNEY RINSE-4
    FORMA-TAG USP SODIUM CHLORIDE PACKAGE 80GM & 120 G
    WAREXIN RECOMMENDED ALTERNATIVE DIALYZ
    ADAPTOR HR-3000 REUSE
    RENATRON
    FORMA-FAS-TEST
    ULTRAMAX
    ECHO MM1000
    HPR HOME PATIENT RENATRON
    DIALYZER PREPARATION SYS DPS-4
    COMPUDIAL/KP-1
    SPORIDIDIN-D COLD STERILIZING/SOLUTION
    AHR-3000 RE-USE ADAPTOR
    RENALIN (TENTATIVE
    RENATRON DIALYZER REPROCESSING SYS

    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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