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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: EZN FDA class 2

    Dilator, Catheter, Ureteral

    Gastroenterology, Urology

    View full classification →

    The Ureteral Catheter Dilator (product code EZN) is a medical instrument used to gradually widen the ureter to facilitate passage of catheters or to treat ureteral strictures. It is an FDA Class 2 device (moderate risk), requiring 510(k) premarket clearance. It is regulated under 21 CFR 876.5470 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
    Optilume® High Pressure Urological Balloon Dilation Catheter
    ARMADA Ureteral Dilator Set, ARMADA Nottingham One Step Dilator, ARMADA Amplatz Renal Dilator Sets, ARMADA Renal Dilator, Glider Amplatz Sheath, ARMADA Renal Dilator with Amplatz Sheath, Fascial Dilator Set, Introducer Sheath, Introducer Catheter
    In-Ka Ureteral Balloon Dilatation Catheter
    EQUINOX Balloon Dilatation Catheter
    Ureteral Dilator Sets, Ureteral Dilators
    Safety Wire Guide Introducer
    Cook 810 Set, Desilets-Hoffman Introducer Set
    Balloon Catheter and Balloon Ureteral Dilator Set
    Ureteral Dilators and Percutaneous Nephrostomy Dilators
    GYRUS ACMI URO-EZDILATE URETERAL BALLOON DILATION CATHETER
    UROMAX ULTRA BALLOON DILATATION CATHETER
    PATHWAY BALLOON EXPANDABLE URETERAL ACCESS SHEATH, MODEL BEUS
    U-BALLOON DILATION CATHETER
    PATHWAY URETERAL ACCESS SHEATH, PATHWAY EXPANDABLE URETERAL ACCESS SHEATH
    COOK URETERAL BALLOON DILATION CATHETER SET
    PATHWAY ACCESS SHEATH CATHETER
    BARD UROFORCE BALLOON DILATION CATHETER
    BALLOON URETERAL DILATORS, ACCENT DG BALLOON URETERAL DILATOR SET, ASCEND BALLOON DILATION CATHETERS, BALLOON DILATION C
    UROLOGICAL BALLOON DILATATION CATHETER
    ASCEND BALLOON DAILATION CATHETER
    BARD A-TRAC UROLOGICAL BALLOON DILATION CATHETER
    MS CLASSIQUE BALLOON CATHETER W/HYDROPASS COATING
    NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATION CATHETER
    DILATATION CATHETER, BALLOON
    MEADOX SURGIMED NOPROFILE(TM) OLBERT CATHETER SYSTEM(R)
    PASSPORT
    ENTRAC URETERAL BALLOON DILATATION CATHETERS
    NAMIC ARIA(TM) INFLATION DEVICE
    UROLOGICAL BALLOON DILATATION CATHETER
    MICROVASIVE UROLOGICAL BALLOON DILATION CATHETER
    ENTRAC URETERAL BALLOON DILATION CATHETERS
    UROLOGICAL BALLOON DILATATION CATHETER
    URETEROMAT 4400
    ACCENT DG BALLOON URTERAL DILATOR SET, 10CM
    CATHETER, URETERAL DILATOR
    URS-HYDRO-DILATOR MODEL NUMBER 2164.00
    ACCENT DG BALLOON URETERAL DILATOR SET
    NO PROFILE OLBERT CATHETER SYSTEM FOR UROLOGY
    MEADOX(R) SURGIMED OLBERT CATH SYST FOR UROLOGY
    URETERAL BALLOON DILATATION CATHETER
    BALLOON DILATION CATHETER
    AMCATH URETERAL DILATORS MODELS 7100,7110,7120
    URETHRAL AND URETERAL BALLOON DILATATORS
    URETERAL BULB DILATORS
    VAN-TEC ONE STEP URETERAL DILATATION CATHETER
    URETERAL DILATOR
    URETERAL DILATOR/SHEATH SET
    OLBERT CATHETER SYS FOR URETERAL DILATION
    URETERAL DILATION SET
    MENTOR PERCUTANEOUS RENAL DILATOR SET

    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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