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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: EZL FDA class 2

    Catheter, Retention Type, Balloon

    Gastroenterology, Urology

    View full classification →

    The Balloon Retention-Type Catheter (product code EZL) is an indwelling urinary catheter fitted with an inflatable balloon near its tip that is inflated after insertion to keep the catheter in position within the bladder. It is an FDA Class 2 device (moderate risk), requiring 510(k) premarket notification. It is regulated under 21 CFR 876.5130 in the Gastroenterology and Urology specialty. This device is eligible for third-party 510(k) review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Silicone Urethral Catheter (Silicone Urethral Catheter)
    InnoCare Specialty Foley Catheter
    Rüsch Latex Gold Foley Catheter
    TraumaGuard Intra-abdominal Pressure Sensing System
    Folysil Silicone Catheter
    2-Way 100% Silicone Cleartract Catheter
    Teleflex Rusch SoftSimplastic Foley Catheters
    Flume Catheter
    Accuryn Monitoring System, Accuryn SmartFoley IAP UO Temp Tray System 12 F, Accuryn SmartFoley IAP UO Temp Tray System 14 F
    2-Way 100% Silicone Cleartract Catheter
    2-Way 100% Silicone ClearTract Catheter
    FLUME catheter
    Well Lead All Silicone Foley Catheter with Temperature Sensor
    Foley Balloon Catheter for Urology
    Prefilled Syringe
    HDX 100% Silicone 2-way Foley Catheter, 14Fr/10cc, HDX 100% Silicone 2-way Foley Catheter, 16Fr/5cc, HDX 100% Silicone 2-way Foley Catheter, 18Fr/10cc
    AquaFlate Pre-Filled Sterile Water Syringe 10mL
    Silicone Foley Catheter
    Urethrotech UCD
    Signal Catheter
    PSM 3-Way Silicone Foley Catheter
    Bard Vertus Foley Catheter
    AMSure Pre-filled Syringe for Balloon Inflation with Sterile Water
    Radiance(TM) Clear Sharklet(R) Silicone Foley Catheter
    CystoSure Plus Catheter
    Yikang Latex Foley Catheter
    Silicone Foley Catheter for single use
    Duette 100% Silicone Dual-Balloon, Temperature-Sensing Catheter
    Kohli Urinary Drainage Catheter
    Rusch Silicone Foley Catheter
    Rusch Simplastic Foley Catheters
    Accuryn Monitoring System
    SilverCoat Silicone Foley Catheter
    Bard LubriGuard Foley Catheter
    Medline Silicone Foley Catheter
    WELL LEAD HYDROPHILIC SILICONE FOLEY CATHETER
    LIGHTHOUSE URINARY CATHETER
    LIGHTHOUSE(TM) URINARY CATHETER
    DISPOSABLE SILICONE FOLEY CATHETER
    TEMPERATURE SENSOR CATHETER
    DIRECTVISION CATHETER, UNCOATED
    COUDE/ OR TIEMANN
    AMSURE 3-WAY HYDROPHILIC LATEX FOLEY CATHETER
    WELL LEAD SILICONE CATHETER WITH TEMPERATURE SENSOR
    3 WAY SILICONE FOLEY BALLOON CATHETER
    AMSURE HYDROPHILIC LATEX FOLEY CATHETER
    PERCUCATH URINARY CATHETER
    UC-CARE POSITIONING SYSTEM
    WELL LEAD SILICONE AND LATEX FOLEY CATHETERS
    BARDEX LUBRI-SIL AND BARDEX LUBRI-SIL I.C. ANTI-INFECTIVE ALL-SILICONE FOLEY CATHETERS

    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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