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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: HLI FDA class 2

    Ophthalmoscope, Ac-Powered

    Ophthalmic

    View full classification →

    The AC-Powered Ophthalmoscope is an electrically powered instrument used by clinicians to illuminate and examine the interior of the eye, including the retina, optic disc, macula, and blood vessels, for the diagnosis of ocular and systemic diseases. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification to demonstrate substantial equivalence to a predicate device. The product code is HLI, regulated under 21 CFR 886.1570, within the Ophthalmic medical specialty. No special risk flags apply to this device.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    RTVue XR OCT Avanti with AngioVue Software
    EnFocus 2300, EnFocus 4400
    OCT-Camera
    PROPPER INSIGHT BINOCULAR INDIRECT OPHTHALMOSOPE
    CENTERVUE MACULAR INTEGRITY ASSESSMENT
    AMICO DH-W35 OPHTHALMOSCOPE SERIES
    IVUE 500
    HEINE OMEGA 500
    IVUE WITH NORMATIVE DATABASE
    ENVISU SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM (SDOIS)
    RTVUE XR OCT
    RHA2020
    ISTAND
    AAIO-7, AAIO WIRLESS
    RTVUE MODEL RTVUE 100
    R T VUE WITH SOFTWARE 5.0 MODEL: R I VUE 100
    CIRRUS HD-OCT, MODEL 4000
    BIOPTIGEN SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM
    RTA 5 & RTA MODEL E RETINAL THICKNESS ANALYZER
    VANTAGE INDIRECT OPHTHALMOSCOPE
    VISANTE OCT
    OCT-OPTHALMOSCOPE
    PANORAMIC 200A
    RTA MODEL D RETINAL THICKNESS ANALYZER
    STRATUSOCT WITH RNFL & MACULA NORMATIVE DATABASE
    RTA MODEL D RETINAL THICKNESS ANALYZER
    STRATUSOCT WITH RNFL NORMATIVE DATABASE
    WELCH ALLYN 11800 OPTHALMOSCOPE
    CLINICAL SPECULAR MICROSCOPE, MODEL HAI CL-1000XYZ
    CANON LASER BLOOD FLOWMETER (CLBF) MODEL 100
    MODIFICATION TO RTA RETINAL THICKNESS ANALYZER
    PANORAMIC200 OPTHALMOSCOPE
    S2LO
    HEIDELBERG RETINA ANGIOGRAPH FA/ICGA (HRA/C)
    SCHEPENS-YOSHIDA VIDEO BINOCULAR INDIRECT OPHTHALMSCOPE
    RTA RETINAL THICKNESS ANALYZER
    HUMPHREY OCT SCANNER
    ANGIOSCAN (AS STAND ALONE INSTRUMENT)
    WELCH ALLYN VIDEO OPHTHALMOSCOPE
    INDIRECT OPHTHALMOSCOPE VIDEO SYSTEM IO0 A TV
    WELCH ALLYN OPHTHALMOSCOPE
    RETINA TOMOGRAPH AND FLOWMETER
    RETINA FLOWMETER
    RETINA ANGIOGRAPH
    NEITZ HALOGEN OPHTHALMOSCOPE BXA-RC
    NEITZ HALOGEN BINOCULAR INDIRECT OPHTHALMOSCOPE IO-A
    NEITZ HALOGEN OPHTHALMOSCOPE BXA-123
    NEITZ HALOGEN OPHTHALMOSCOPE BXA-12
    NEITZ HALOGEN OPHTHALMOSCOPE BXA-RP
    NEITZ HALOGEN BINOCULAR INDIRECT OPHTHALMOSCOPE IO-H

    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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