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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: HMX FDA class 1

    Cannula, Ophthalmic

    Ophthalmic

    View full classification →

    The Ophthalmic Cannula is a thin, hollow tube used in ocular surgery to irrigate, aspirate, or inject fluids into anterior or posterior ocular structures during procedures such as cataract extraction or vitreoretinal surgery. It is classified as FDA Class 1, the lowest risk level, subject only to general controls without a premarket notification requirement. The product code is HMX, regulated under 21 CFR 886.4350, within the Ophthalmic medical specialty. No special risk flags apply to this device.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    WEISS RETINAL CANNULA
    VERTEFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 11000 SERIES; PHOTOFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 12000 SERIES
    ENDOSOFT SOFT TIP NEEDLE (20 GA. AND 19 GA.)
    STERISEAL OPHTHALMIC CANNULA
    INFUSION CANNULA
    INTER TIP T
    KIRWAN IRRIGATION/ASPIRATION HANDPIECE
    ASPIRATING ENDO OCULAR PROBE W/ILLUMINATION
    IRRIGATOR/ASPIRATOR PROBE
    VITREORETINAL INFUSION CANNULA
    OCULAR INFUSION CANNULA SYSTEM
    GRIESHABER SOFT TIP NEEDLE (20 & 19 GAUGES)
    STORZ INFUSION CANNULA
    ANESTHESIA/RETROBULBAR NEEDLES
    OCU-1
    CANNULAS
    OPHTHALMIC CANNULA
    PRISMA DISPOSABLE VISCOELASTIC I/A CANNULA
    PRISMA DISPOSABLE DOUBLE I/A CANNULA
    PRISMA DISPOSABLE LEWICKY CHAMBER MAINTAINER
    PRISMA DISPOS. TROUTMAN ALPHA-CHYMOTRYPSIN CANNULA
    PRISMA DISPOSABLE MICRO IRRIGATING VECTUS
    PRISMA DISPOSABLE KRATZ CAPSULE POLISHER
    PRISMA DISPOSABLE SIMCOE I/A CANNULA
    PRISMA DISPOSABLE SIMCOE EXTRACTOR
    PRISMA DISPOSABLE U-SHAPED CANNULA
    PRISMA DISPOSABLE SILICONE BULB
    PRISMA DISPOS. CURVED LACHRYMAL CANNULA
    PRISMA DISPOSABLE SIMCOE CAPSULE POLISHER
    PRISMA DISPOSABLE J-SHAPED I/A CANNULA
    PRISMA DISPOSABLE KUGLEN IRRIGATING LENS MANIPULA.
    PRISMA DISPOSABLE RETROBULBAR NEEDLE
    PRISMA DISPOS. BISHOP-HARMON IRRIGATING CANNULA
    PRISMA DISPOSA. RYCROFT ANTERIOR CHAMBER CANNULA
    PRISMA DISPOSABLE ANGLED I/A CANNULA
    PRISMA DISPOS. PEARCE IRRIGATING VECTUS W/ONE PORT
    PRISMA DISPOSABLE ADAPTER FOR IRRIGATORS
    PRISMA DISPOSABLE PUPIL CENTERING CANNULA
    PRISMA DISPOSABLE PEARCE IRRIGATING VECTUS
    PRISMA DISPOSABLE ATKINSON RETROBULBAR NEEDLE
    PRISMA DISPOSABLE GILLS ANGLED I/A CANNULA
    PRISMA DISPOSABLE IRRIGATING LENS DIALER
    PRISMA DISPOSABLE DOUBLE I/A CANNULA CLOSED
    PRISMA DISPOSABLE CAPSULE POLISHER
    DISPOSABLE INFUSION CANNULA 0045-1/2/3 2.5/4.0/6.0
    VAN DELLEN HEALON CANNULA
    VAN DELLEN RETROBULBAR NEEDLE
    LOOK IRRIGATING/ASPIRATING CANNULA W/TEFLON SHEATH
    SOLOS EYESITE CANNULAS
    HAMACHER BULLET POINT OPHTHALMIC NEEDLE

    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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