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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: LYK FDA class 2

    Angioscope

    Gastroenterology, Urology

    View full classification →

    The Angioscope (product code LYK) is a minimally invasive cardiovascular instrument consisting of a flexible fiberoptic endoscope used to directly visualize the interior of blood vessels, enabling assessment of vascular lesions, thrombi, and valve function. Regulated under 21 CFR 876.1500 and classified as a Class 2 device, it requires a 510(k) premarket notification and falls under the Gastroenterology/Urology specialty with review by the Cardiovascular (CV) panel. It is not an implant and is not life-sustaining.

    510(k) Clearances

    39 matches
    K Number
    Device Name
    CARDIOOPTICS AUGMENTATIVE CARDIAC OPTICAL IMAGING SYSTEM
    CORONARY SINUS ACCESS KIT, MODEL KCS8F-01
    KSEA FIBERSCOPE
    SMITH & NEPHEW VASCULAR VIDEOENDOSCOPE SYSTEM, MODEL 7209273
    KSEA VASCULAR FIBERSCOPES
    GORE ANGIOSCOPIC VALVVLOTOME KIT (TBD)
    4.5F IMAGECATH CORONARY ANGIOSCOPE, MODEL COV45 [SUBSEQUENTLY REFERRED TO AS THE MODIFIED ANGIOSCOPE[
    APPLIED MEDICAL 1.5MM REUSABLE ANGIOSCOPE
    APPLIED MEDICAL OPTICAL VALVULOTOME
    ULTATHIN FLEXIBLE ENDOSCOPE
    ANGIOSCOPE
    BAXTER CORONARY ANGIOSCOPE INFLATION DEVICE
    DIAGNOSTIC INTRAVASCULAR CATHETER
    DISPOSABLE STEERABLE ANGIOSCOPE
    4.5F IMAGECATH(R) CORONARY ANGIOSCOPE, COV45
    CLARUS SERIRS 2200 SEMI-RIGID ENDOSCOPE
    DISPOSABLE VASCULAR ANGIOSCOPE
    AMETEC MASY MODULAR ANGIOSCOPE SYSTEM
    DISPOSABLE VASCULAR ANGIOSCOPE
    ANGIOLAZ ANGIOSCOPE CATHETER
    INTERPRET(TM) CATHETER LINEAR TRANSLATOR
    OMEGA ANGIOSCOPES (OMEGASCOPES)
    OLYMPUS AF ANGIOSCOPE SYSTEM
    4.5F IMAGECATH ANGIOSCOPE
    ULTRA-VU ANGIOSCOPE
    ANGIOSCOPE W/THE OPTISCOPE-2 INTEGRATED ANGIOSCOPY
    INTRAVASCULAR IMAGING SYSTEMS
    CVIS INSIGHT IMAGING CATHETER
    INTRAVASCULAR IMAGING SYSTEM
    ANGIOSCOPE
    HEMOLASER HEMOSCOPE
    VASCUCARE PERCUTANEOUS ANGIOSCOPY DELIVERY SYSTEM
    ACS ANGIOSCOPE GUIDE WIRE
    ACS CORONARY ANGIOSCOPIC CATHETER
    OLYMPUS PF-18 & PF-25 ULTRATHIN ANGIOSCOPE
    AMERICAN EDWARDS MINI-FLEX ANGIOSCOPE
    ANGIOSCOPY CATHETER
    ANGIOSCOPY CATHETER
    ANGIOSCOPE

    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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