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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: KOD FDA class 2

    Catheter, Urological

    Gastroenterology, Urology

    View full classification →

    A Urological Catheter is a flexible tube inserted into the urinary bladder through the urethra to drain urine, instill medications, or perform urological procedures in patients with urinary retention, obstruction, or incontinence. It is classified as FDA Class 2, indicating moderate risk requiring 510(k) premarket notification. The product code is KOD and the applicable regulation is 21 CFR 876.5130 in the Gastroenterology and Urology specialty. This device is eligible for third-party review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Wellead Ureteral Catheter
    allFlex Ureteral Catheters, Krait Ureteral Catheters
    Urinary Catheter 12 Fr, Urinary Catheter 16 Fr
    Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter
    UroGen Ureteral Catheter
    Angled Tip Ureteral Catheter
    Imager II Urology Torque Catheter
    Cone Tip Ureteral Catheter, Rutner Universal Wedge Catheter
    Renal Access Cobra Catheter, Kumpe Access Catheter
    Open-End Ureteral Catheter, Open-End Ureteral Catheter Sof-Flex, EchoTip Open-End Ureteral Catheter, Open-End Flexi-Tip Ureteral Catheter, Flexi-Tip Ureteral Catheter (Closed End), Whistle Tip Ureteral Catheter, Round Tip Ureteral Catheter, Spiral Tip Ureteral Access Catheter, Pediatric Ureteral Catheter
    GentleCath Intermittent Urinary Catheter
    GentleCath Glide Intermittent Catheter
    United Urologics Closed System Catheter
    GENTLECATH MALE COUDE OLIVE TIP INTERMITTENT URINARY CATHETER
    BACKSTOP CATHETER
    BACKSTOP CATHETER
    IMAGER II UROLOGY TORQUE CATHETER (C1 TIP); IMAGER II UROLOGY TORQUE CATHETER (C2 TIP; IMAGER II UROLOGY TORQUE CATHETER
    BACKSTOP CATHETER, MODEL 60-0000-3100
    MTG INSTANT CATHER (WITH AND WITHOUT KIT), MTG INSTANT CATH DELUXE (WITH AND WITHOUT KIT)
    CURE CATHETER CLOSED SYSTEM
    DOVER ROB-NEL CATHETER
    DOVER RED RUBBER ROBINSON CATHETER
    BARD TIGERTAIL URETERAL CATHETER
    CLOSED SYSTEM INTERMITTENT CATHETERIZATION KIT
    INTERMITTENT URETHRAL CATHETERS
    URETERAL ACCESS SHEATH SET (UASS)
    INCARE ADVANCE; INTERMITTENT CATHETER, PLUS INTERMITTENT CATHETER, PLUS KIT
    INCARE INTERMITTENT CATHETER
    IMAGER II UROLOGY TORQUE CATHETER, MODEL 40030X1, 40040X1, AND 40050X1
    ENDOCARE PERCUTANEOUS ACCESS SET
    ENDOCARE PERCUTANEOUS ACCESS SET
    ISLAND BIOSURGICAL BNS KIT #3
    HYDROPHILIC SILICONE FOLEY CATHETER AND PERSONAL CATHETER (HYDROPHILIC AND NON-HYDROPHILIC)
    FLOCATH
    IMAGER TORQUE CATHETER
    URINARY INTERMITTENT CATHETERS W/O HYDROMER HYDROPHILIC LUBRICANT
    NOPROFILE OLBERT CATHETER SYSTEM
    BARD URODYNAMIC CATHETERIZATION PROCEDURE TRAY
    4SURE URO-LINK UROLOGICAL PROCEDURE TRAYS
    FLOWMATE HAND PUMP
    PERCUTANEOUS DRAINAGE LOOP CATHETER SET
    KENDALL CURITY 100% SILICONE FOLEY CATHETER W/TEMPERATURE SENSOR
    ONIK-COHEN ACCESS SET
    FOLEY INSERTION TRAY
    KIT PAK'S FLUSHING KIT
    BARD LATEX URINARY CATHETERS
    RADIFOCUS GUIDE WIRE M
    KENDALL MOD. PEDIATRIC ULTRAMER POLYURETHANE CATH.
    IRRIGATION TUBING SET
    INSTRUMENT IRRIGATION PUMP

    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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