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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: KOC FDA class 2

    Accessories, Blood Circuit, Hemodialysis

    Gastroenterology, Urology

    View full classification →

    Hemodialysis Blood Circuit Accessories are components used as part of the extracorporeal blood circuit in hemodialysis systems, including tubing, connectors, blood pumps, and pressure monitors that facilitate the circulation of blood outside the body during renal dialysis treatment. It is classified as FDA Class 2, indicating moderate risk requiring 510(k) premarket clearance. The product code is KOC and it is regulated under 21 CFR 876.5820 in the Gastroenterology and Urology specialty. This device is classified as life-sustaining or life-supporting.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series (AL-ADC-E(U), AL-CDC-E(U), C18RDC-E(U), C18BDD-E(U), C18SFD-E(U)
    BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series AL-ADC-PU, AL-CDC-PU, C18RDC-PU, C18BDD-PU, C18SFD-PU
    Blood Tubing Lines for Hemodialysis AV06C-E
    Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for Hemodialysis C18 Series
    CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Integrated Crit-Line Technology, CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Intergrated Crit-Line Technology, no Heparin Line
    CAREline Airless Hemodialysis Blood Tubing Sets
    CRIT-LINE III Blood Chamber II
    CRIT-LINE CLIP (CLIC) BLOOD CHAMBER
    CRIT-LINE IV SYSTEM
    CRIT-LINE CLIP (CLIC) BLOOD CHAMBER
    CRIT-LINE CLIP (CLIC)
    NIKKLINE BLOOD TUBING LINES WITH TRANSDUCER PROTECTORS, MODELS AV06A-P, AVO6B-P, AV06C-P
    HEMOBAND, MODELS HB-NS AND HB-NSXL
    PRISMAFLO II
    LEAK DETECTION SENSOR AND TRAY ACCESSORY KIT
    PRISMACOMFORT, MODEL AUTOCONTROL 3XPT WITH AUTOLINE XPT 4R
    VASC-ALERT
    \RESENIUS ACCESS FLOW RESERVING CONNECTORS, FRESENIUS STANDALONE ACCCES FLOW RESERVING CONNECTOR
    PRISMAFLO
    MODIFICATION TO MALE TO MALE LUER ADAPTER
    FRESENIUS PRIMING SET WITH NEEDLES ACCESS PORT, MODEL 04-9002-9
    TRANSONIC HEMODIALYSIS FLOW REVERSER, MODEL B FLOWREV
    ACCESS ALERT GAUGE
    REVERSO
    JMS DIALYZER PRIMING SET
    NIPRO BLOOD TUBING SET WITH TRANSDUCER AND SOLUTION SET FOR HEMODIALYSIS
    MEDISYSTEMS DIALYSIS PRIMING SETS
    NIPRO ARTERIAL & VENOUS BLOOD TUBING SET FOR HEMODIALYSIS
    CUTANEOUS COMPRESSION DEVICE FOR USE IN HEMODIALYSIS
    ARTERIAL BLOOD TUBING SET FOR SINGLE NEEDLE HEMODIALYSIS
    DIALYSIS ADMINISTRATION KITS
    KARL STORZ MODIFIED VERESS NEEDLE AND CANNULA
    DUAL LUMEN CATHETER (DLC) TRAY
    DIAL MEDICAL KIT
    PRISM MEDICAL CUSTOM DIALYSIS KIT
    CRIT-LINE BLOOD CHAMBER WITH E-BEAM
    SILICONE CATHETER REPAIR KITS
    CENTRYSYSTEM 3 WITH CHARTS/BP OPTION
    CD HOME DIALYSERVICE HEMODIALYSIS TRAY
    BARD UROTRACK II MONITORING
    RS-1000
    DIGI -FLOW
    HEMO-BAND
    BARD(R) UROTACK(R) 210 MONITORING SYSTEM
    DRAIN/PRIMING/RECIRCULATION BAG
    EXTRACORPOREAL BLOOD PUMPING SYST FOR HEMOFILTRAT
    MINNILERT(R) PRESSURE MONITOR
    MODEL BAXTER ULTRAFILTRATE METER AND DRAIN BAG
    INTRODUCER NEEDLES
    Y ADAPTOR

    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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