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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: KNY FDA class 2

    Accessories, Catheter, G-U

    Gastroenterology, Urology

    View full classification →

    Genitourinary Catheter Accessories are supplementary devices used in conjunction with urological catheters, including connectors, caps, drainage bags, and stabilization components that support catheter management and urinary drainage in clinical and home care settings. It is classified as FDA Class 2, indicating moderate risk requiring 510(k) premarket notification. The product code is KNY and it is regulated under 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
    Bi-Flex Evo
    Vesair Cystoscopic Sheath
    BI-FLEX URETERAL ACCESS SHEATH
    WIJAY EZ-VOID EXTERNAL CATHETER VALVE
    GUARDIAN URETHRAL SHEATH
    GUARDIAN URETHRAL SHEATH
    VARI-PASS VARIABLE LENGTH ACCESS SHEATH
    ROCAMED ROCAUS PLATINUM
    PREFILLED CATHETER INFLATION SYRINGE
    PRE-FILLED CATHETER INFLATION SYRINGE
    CYSTOGLIDE INTRODUCER SHEATH
    CAREVENT
    CATHASSIST
    CYSTOGLIDE DILATING INTRODUCER SHEATH
    UROPASS URETERAL ACCESS SHEATH, MODEL 61224
    UPDATED SLIP UROLOGY INTRODUCER SHEATH
    MICROVERTER URETERAL ACCESS SHEATH
    SLIP UROLOGY INTRODUCER SHEATH
    HEMEDEX FIXATION DEVICE
    CATHETER CONNECTOR
    MEMCATH UROLOGY INTRODUCER SHEATH, MODEL 201
    PBN DRAINAGE CATHETER GUIDEWIRES
    SNAP-N-PEEL INTRODUCERS
    HYDROPHILIC COATED GUIDEWIRE
    MANAN MANTA CATHETER FIXATION DISK
    INSULATOR WIRE GUIDE
    LRM PRODUCES GUIDEWIRES ON AN OEM BASIS FOR MANUFACTURERS,KIT ASSEMBLERS, AND DISTRIBUTORS.
    MANAN MANTA CATHETER FIXATION DISK
    PREFILLED SYRINGE FOR INFLATION OF FOLEY CATHETER
    KARL STORZ CATHETERS, MANDRIN, PLUGS, CONNECTOR
    KENDALL CURITY CATHETER PLUG WITH PROTECTIVE CAP
    PRE-FILLED SYRINGE W/STERILE .25% ACETC ACID
    AMPLATZ SUPER STIFF GUIDEWIRE
    UROLOGICAL GUIDWIRE
    CONVENIENCE CONTOUR KITS REDI NURSE SYSTEM
    ZEBRA UROLOGICAL GUIDEWIRE
    FLEXFINDER GUIDEWIRE
    SYRIGENE ACETIC ACID PRE-FILLEDSYRINGE
    FLEXI-TRAK ANCHORING DEVICE
    FOLEY CATHETER TRAY
    GUIDE-TECH ENCAPSULATED GUIDEWIRE
    NORTEC STERILE WATER FOR CATHETER BALLOON INFLATIO
    URINARY CARE SUPPLIES
    KIT PAK URINARY CARE SUPPLIES
    HYDROPHILIC COATED GUIDEWIRE
    GUIDEWIRE
    KENDALL CURITY KIDS PEDIATRIC DRAINAGE ADAPTER
    MENTOR INFUSION LINE
    CATH CONTROL
    UNIVERSAL SWIVEL PATCH

    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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