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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: KYG FDA class 1

    Device, Irrigation, Ocular Surgery

    Ophthalmic

    View full classification →

    The Ocular Surgery Irrigation Device is an ophthalmic device used to continuously bathe and irrigate the eye during surgical procedures, maintaining intraocular pressure and removing debris, blood, or surgical byproducts from the surgical field. It is classified as FDA Class 1, the lowest risk category, subject to general controls only, with no premarket submission required. The product code is KYG, regulated under 21 CFR 886.4360, in the Ophthalmic medical specialty. No special flags apply to this device.

    510(k) Clearances

    40 matches
    K Number
    Device Name
    MED-LOGICS DISPOSABLE ALK TUBING
    TURBO-FLOW INFUSION CANNULA 19 GAGE,20 GAGE,23 GAGE, 25 GAGE, MODEL 101019,101020,101023,101025
    BLADEWORKS DISPOSABLE ALK TUBING
    SOVEREIGN CATARACT EXTRACTION SYSTEM
    EYE IRRIGATOR MODEL #2020
    MOISTAIR FLUID AIR TUBING SET
    ML DISPOSABLE ALK TUBING
    HEDGES CORNEAL WETTING PAK
    D.O.R.C. VFI/VFE SYSTEM
    DISPOSABLE & RESUABLE IRRIGATION/ASPIRATION HANDPIECE
    PEREGRINE PIC MINIPULATOR
    I/V POLE
    ELECTRIC I/V POLE OR EIVP2
    MODIFIED SITE DISPOSABLE DIAPHRAGM CASSETTE
    AUTOPOLE REGULATOR SYSTEM
    INFINITY MICRO IRRIGATOR
    MODIFIED SITE DIAPHRAGM CASSETTE FOR OPHTHALMICS
    LEWICKY O.R.S. TUBING
    AQUEOUS PARACENTESIS PIPET
    GRIESHABER AIR/FLUID TUBING SET
    SITE DIAPHRAGM CASSETTE
    INFUSION HANDLE
    B & B I/A HANDPIECE
    ALCON SITE(R)-COMPATIBLE CASSETTE
    UNI-PORT
    MORGAN THERAPEUTIC LENS
    MULTI-SPIKE
    BACSTOP FILTER IRRIGATION SUPPLY KIT
    ELECTRICALLY CONTROLLED I.V. POLE (OPTHALMIC)
    VISITEC IRRIGATION CONTROL SYSTEM
    OPERAID DISPOS. IRRIGATING KNIFE
    OPERAID NUCLEUS
    ELECATH HEPARIN COATED THERMAL DILUTION
    MICRO SURGICAL HANDLE
    LENS
    ASPIRATOR/IRRIGATOR OR I/A UNIT
    DISPOSABLE TUBING SETS
    INTRAJECT
    NU-VISION DISP. OPHTHALMIC DRESSING TRAY
    NALGENE EMERGENCY EYE WASH

    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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