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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: OBO FDA class 2

    Tomography, Optical Coherence

    Ophthalmic

    View full classification →

    The Optical Coherence Tomography (OCT) system (product code OBO) is an ophthalmic diagnostic device used for viewing, imaging, measurement, and analysis of ocular structures, aiding in the detection and management of various ocular diseases such as glaucoma, macular degeneration, and diabetic retinopathy. OCT uses light-based interferometry to generate high-resolution cross-sectional images of retinal layers and other ocular tissues. This device is FDA Class 2 under regulation 886.1570 in the Ophthalmic specialty, requiring 510(k) clearance and compliance with general and special controls. It carries no implant or life-sustaining flags.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    SPECTRALIS HRA+OCT and variants
    Anterion
    SPECTRALIS with Flex Module
    3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic Data System
    SPECTRALIS HRA+OCT and variants
    CIRRUS™ HD-OCT Model 6000
    P200TE (A10700)
    3D Optical Coherence Tomography (3D OCT-1(type: Maestro2))
    RESCAN 700
    3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2)
    SPECTRALIS HRA+OCT and variants
    Anterion
    MS-39
    P200TE (A10700)
    CIRRUS HD-OCT
    Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing Software NAVIS-EX; Scanning Laser Ophthalmoscope Mirante [SLO Model] with Image Filing Software NAVIS-EX
    SOLIX
    Tomey Cornea/Anterior Segment OCT CASIA2
    Anterion
    Spectralis HRA+OCT and variants
    OCT-Camera ID 21101A3
    Spectralis HRA+OCT and Variants
    P200TxE
    Canon OCT-A1
    CIRRUS HD-OCT
    RESCAN 700, CALLISTO eye
    Spectralis HRA+OCT and variants with High Magnification Module
    Spectralis HRA+OCT and variants with OCT Angiography Module
    Spectralis HRA + OCT and variants
    Avanti
    P200TE
    DRI OCT Triton
    Spectralis HRA + OCT and variants, Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT with Multicolor
    PRIMUS
    iVue
    3D OCT-1 Maestro
    EnFocus 2300, EnFocus 4400
    PLEX Elite 9000 SS-OCT
    3D OCT-1 Maestro
    Spectralis HRA + OCT and variants (e.g.s below), Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT ith Multicolor
    CIRRUS HD-OCT
    RESCAN 700, CALLISTO EYE
    CIRRUS PHOTO
    RS-3000 ADVANCE
    NIDEK RS-3000
    OPTOS OCT/SLO MICROPERIMETER
    SPECTRALIS HRA + OCT AND VARIANTS, SPECTRALIS FA+ OCT, SPECTRALIS ICGA +OCT, SPECTRALIS OCT BLUE PEAK, SPECTRALIS OCT
    CIRRUS PHOTO
    CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER, MACULAR, OPTIC NERVE HEAD, and GANGLION CELL NORMATIVE DATABASES
    SPECTRALIS ANTERIOR SEGMENT MODULE (SPECTRALIS ASM)

    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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