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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: HNO FDA class 1

    Keratome, Ac-Powered

    Ophthalmic

    View full classification →

    An AC-Powered Keratome is an electrically powered surgical instrument used to make precise lamellar cuts in the cornea, particularly in keratoplasty (corneal transplantation) or refractive surgical procedures. This device is FDA Class 1 (lowest risk), subject to general controls only and not requiring premarket approval. It carries product code HNO and is regulated under 21 CFR 886.4370, within the Ophthalmic medical specialty. It is eligible for third-party review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    VisuMax Femtosecond Laser
    EPI K Console
    EPIVISION SL SYSTEM
    CARRIAZO-PENDULAR MICROKERATOME
    ZYOPTIX XP EPI SEPARATOR SYSTEM
    HORIZON EPIKERATOME DISPOSABLE MICROKERATOME SYSTEM
    NORWOOD ABBEY CENTURION SES EPIKERATOME
    EPI-K
    AMADEUS II EPIKERATOME
    MODIFICATION TO VISITOME 20-10 MICROKERATOME
    CENTURION SES EPIKERATOME
    MB 105 MILLENNIUM BLADES
    EPITOME SYSTEM
    CARRIAZO PENDULAR
    M3 MICROKERATOME
    M2 COMPATIBLE MICROKERATOME BLADE
    PRIZM KERATOME BLADE, MODEL MK8512M2
    ZYOPTIX XP MICROKERATOME
    PRIZM KERATOME BLADE (B.D. MODEL), MODEL MK8530BD
    MED-LOGICS, MODEL ML7090
    MODIFICATION TO CIBA VISION CENTURION SES SPIKERATOME
    DISPOSABLE N-PE MICKROKERATOME BLADES
    CENTURION SES EPIKERATOME
    DISPOSABLE M2-PE MICROKERATOME BLADES
    SURGISTAR MICROKERATOME BLADE, MODEL NO. 2400-LSK
    KERATOME BLADE 200200 & 600600
    MED-LOGICS MICROKERATOME BLADE, MODEL 7050CLB
    MED-LOGICS MICROKERATOME BLADE, MODEL 7020CLB
    DISPOSABLE N-PE MICROKERATOME BLADES
    HANSATOME EXCELLUS MICROKERATOME
    BLADEWORKS MICROKERATOME BLADE, MODEL 7061
    VISTITOME 20-10 MICROKERATOME
    MB 103 MILLENNIUM BLADES
    MB 102 MILLENNIUM BLADES
    PRIZM KERATOME BLADE (NIDEK MODEL), MODEL MK8514NI
    PRIZM BLADE (MORIA MODEL) LSK / MK8510LSK; PRIZM BLADE (MORIA MODEL) CB / MK8511CB
    ML BLADE, MODEL ML7030
    HANSATOME MICROKERATOME
    DISPOSABLE CB-PE MICROKERATOME BLADES
    MEDLOGICS ML 4000, MODEL 4000
    MILLENNIUM BLADES, MODEL MB101
    PRECISIONEDGE-ACC, PRECISIONEDGE-ACS, PRECISIONEDGE-LSK, AND PRECISIONEDGE-CB MICROKEATOME BLADES
    DISPOSABLE H-PE MICROKERATOME BLADES
    DISPOSABLE MICROKERATOME BLADES-PE
    REFRACTIVE SURGERY BLADES
    ULTRAEDGE KERATOME BLADE, MODEL 374803 - ACS
    BLADEWORKS MICROKERATOME BLADE
    MSP M/K BLADE
    ACCUBLADE (ACS MODEL), MK8507, ACCUBLADE (HANSOTOME MODEL), MK8508
    ADVANCED COMPUTER CONTROLLED MICROKERATOME-ACCM, MODEL SURGICAL INSTRUMENT SYSTEMS (SIS)

    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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