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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: MPB FDA class 2

    Catheter, Hemodialysis, Non-Implanted

    Gastroenterology, Urology

    View full classification →

    The Non-Implanted Hemodialysis Catheter is a urology device inserted into a large vein (such as the jugular or subclavian) to provide temporary vascular access for hemodialysis in patients with acute or chronic kidney failure. Classified as FDA Class 2 under 21 CFR 876.5540, it requires 510(k) premarket notification. The product code is MPB, and it carries a life-sustaining support flag given its critical role in patients dependent on dialysis.

    510(k) Clearances

    37 matches
    K Number
    Device Name
    Acute Dual Lumen Hemodialysis Catheter
    Duo-Flow Side x Side Double Lumen Catheter
    Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen Catheter, Mahurkar Acute Triple Lumen Catheter, Mahurkar Acute High Pressure Triple Lumen Catheter
    Zenysis Short-Term Dialysis Catheter
    Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray
    Zenysis Short-Term Dialysis Catheter
    COOK TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAY COOK SPECTRUM TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAY
    MAHURKAR ELITE ACUTE DUAL LUMEN CATHETER, ELITE ACUTE TRIPLE LUMEN CATHETER
    AMECATH AND AMECATH UNIQATH SOFT SHORT TERM DUAL HEMODIALYSIS CATHETERIZATION KITS
    DISPOSABLE HEMODIALYSIS ACCESS CATHETER SETS
    GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1315 A; AND MS-GDHC-1315J A, GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1320 A; AND MS-GDHC-132
    NIAGARA, NIAGARA SLIM-CATH, AND BREVIA SHORT-TERM CURVED EXTENSION HEMODIALYSIS CATHETERS
    NIPRO SAFETOUCH TULIP SAFETY FISTULA NEEDLE
    D-LINE CATHETER ST, DOUBLE LUMEN ST; EXTRA FLOW
    JMS SYSLOC MINI AVF AND APHERESIS NEEDLE SETS
    GAMCATH HIGH FLOW CATHETER, REF: GDHK 13XX A
    NIAGARA TEMPORARY DUAL LUMEN CATHETERS; FLEXXICON II TEMPORARY DUAL LUMEN CATHETERS
    MAHURKAR OPLUS CATHETER, MODEL 13.5 FR
    TRUFLOW LONG-TERM AND SHORT-TERM DUAL-LUMEN DIALYSIS CATHETERS
    NIAGARA SLIM-CATH
    KEYSTONE MEDICAL SCHON XL SOFT-LINE DOUBLE LUMENT CATHETER. KEYSTONE MEDICAL 12 F DUO-FLOW AND 14F DUO-FLOW 400 XL CATH
    14 FR TWO-LUMEN HEMODIALYSIS CATHERIZATION KIT WITH BLUE FLEXTIP ARROWG+ARD BLUE CATHETER FOR HIGH VOLUME INFUSIONS, PRO
    MEDCOMP DUO-FLOW II CATHETER WITH LUBRICIOUS HEPARIN
    11.5F X 6 (15CM) DUO-SPLIT CATHETER MCDS116MT, 11.5F X 8 (20CM) DUO-SPLIT CATHETER MCDS118MT
    SOFT-LINE IJ DOUBLE LUMEN CATHETER 11.5FR X 12CM, SOFT-LINE IJ DOUBLE LUMEN CATHETER 11.5FR X 15CM, SOFT-LINE LUMEN CATH
    14 FR. HEMODIALYSIS TWO-LUMEN CATHETERIZATION KIT
    PEDIATRIC TWO-LUMEN HEMODIALYSIS CATHERIZATION KIT
    MEDCOMP SCHON XL SOFT-LINE DOUBLE LUMEN CATHETER, 15CM SBF146, MEDCOMP SCHON XL SOFT-LINE DOUBLE LUMEN CATHETER, 20CM SB
    NIAGARA DUAL LUMEN CATHETER
    KENDALL DUAL LUMEN CATHETER
    BRAUN HEMODIALYSIS CATHETER
    MAHURKAR 8 FR DUAL LEMEN CATHETER
    TWIN SILICONE CATHETER
    MODIFIED QUINTON SINGLE LUMEN CATHETER
    QUINTON SINGLE LUMEN CATHETER
    MODIFIED FORMED-EXTENSION MAHURKAR DUAL LUMEN CATH
    10F & 11.5F MAHURKAR DUAL LUMEN CATHETERS, USEABLE

    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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