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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: HLJ FDA class 2

    Ophthalmoscope, Battery-Powered

    Ophthalmic

    View full classification →

    The Battery-Powered Ophthalmoscope is a portable, handheld ophthalmic instrument used to examine the internal structures of the eye, including the retina, optic disc, and retinal vasculature, enabling diagnosis of conditions such as diabetic retinopathy and glaucoma. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket clearance before marketing. The product code is HLJ, regulated under 21 CFR 886.1570, within the Ophthalmic medical specialty. No special risk flags apply to this device.

    510(k) Clearances

    47 matches
    K Number
    Device Name
    HEINE BETA 200, HEINE BETA 200 S, HEINE K 180
    HEINE SIGMA 250 & HEINE SIGMA 250 M2
    HEINE MINI 3000(R) OPHTHALMOSCOPE
    HEINE BETA 200(R) OPHTHALMOSCOPE
    OPHTHALMOSCOPES DIAGNOSTIC INSTRUMENT KITS
    HEINE MINI 3000 LED OPHTHALMOSCOPE
    OTOSCOPE AND OPHTHALMOSCOPE DIAGNOSTIC INSTRUMENT KITS
    PICCOLIGHT E50,PICCOLIGHT E56,EUROLIGHT E10, EUROLIGHT E30, AND EUROLIGHT E36
    66 VISION TECH OPHTHALMOSCOPE, MODELS YZ6E, YZ6F, YZ6G, YZ11, YZ11C, YZ11D, YZ25A
    OPTYSE OPHTHALMOSCOPE
    PRECISION OPTICS CORPORATION VIDEO OPHTHALMOSCOPE, MODEL 2500-VOS
    KEELER WIDE ANGLE OPHTHALMOSCOPE MODEL 1130-P-5004
    MAGNA FORTIS OPHTHALMOSCOPE DIAGNOSTIC KIT
    MS401097-17,MS722-K,MS720,MS721,MS722
    KEELER SPECTRA INDIRECT OPHTHALMOSCOPE
    RI-FORMER WALL MODEL 2,5 V/220 V OR 110 V 3,5 V/220 V OR 110 V, RI-FORMER ANAESTHETIC MODEL 2,5 V/220 V OR 110 C 3,5 V/V
    HALOGEN OPHTHALMO-OTOSCOPE SET BX A - 134
    HALOGEN DIAGNOSTIC SET BX A - 12345
    RI-SCOPE S OTOSCOPE
    FOCOMETER
    NEITZ HALOGEN OPHTHALMOSCOPE BXA-13A
    NEITZ HALOGEN POCKET OPHTHALMOSCOPE A-JR
    NEITZ HALOGEN OPHTHALMOSCOPE BXA-13
    R&D BATTERIES, PART NOS. 5135, 5097, 5444, AND 5502
    REPLACEMENT BATTERIES PART NO. 5098,5135, 5097
    R & D BATTERIES
    DE LUXE
    UNI II
    RI-FORMER
    OPHTHALMOSCOPE
    MIS
    MEDICAL BATTERY PACKS
    ORIEL
    D.L. SCOPE OPHTHALMOSCOPE
    IRAS GLARE TESTER
    VOROSCOPE(TM)
    INDIRECT OPHTHALMOSCOPE
    #SM-3001 OPHTHA OTOSC SET SUBSETS SOLD
    MODEL BX OPHTHALMOSCOPE(BX-RP INCLUDES BATTE HAN)
    POCKET OPHTHALMOSCOPE GH
    PORTABLE ACUIOMETER
    SPECTACLE INDIRECT OPHTHALMOSCOPE
    MEDIC LUX DIAGNOSTIC SETS
    DORC LIGHTWEIGHT BINOCULAR OPHTHALMOSCOP
    EYESCOPE
    SOLA COMMIDO LOUPE
    SOLA SCHULTZE-CROCK OPTHALMOSCOPE

    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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