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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: HQG FDA class 1

    Lens, Spectacle, Non-Custom (Prescription)

    Ophthalmic

    View full classification →

    A Non-Custom Prescription Spectacle Lens is a standard ophthalmic lens manufactured to a defined prescription specification, used in spectacle frames to correct refractive errors including myopia, hyperopia, astigmatism, and presbyopia in patients whose visual needs can be met by stock lens parameters. This device is FDA Class 1 (lowest risk), subject to general controls only without requiring premarket notification. It carries product code HQG and is regulated under 21 CFR 886.5844, within the Ophthalmic medical specialty.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    SUNGLASSES
    0R 160, OR-1.60, AND ORCOLITE 1.60 HIGH INDEX
    MODIFIED OPHTHALMIC OPIR ONUFRYK IMAGE DEFLECTOR
    SEIKO P-6 PROGRESSIVE SPECTACLE LENSES
    NEOLENS PRESCRIPTION SPECTACLE LENS
    CR-39 PLASTIC LENSES FOR EYEGLASSES
    OPHTHALMIC SPECTACLE LENS BLANKS
    SEIKO PLAX DIACOAT II & SEIKO PLAX S.V.P.
    SWIRL - A PRE-MOISTENED CLEANING TISSUE FOR EYES
    AR DIACOAT SINGLE VISION LENSES
    MELANITE I
    MULTIPLE SPECTACLE LENS
    KROM-X LENS SYSTEM
    FORMALENS 2000
    TECHNA VISION CASTING RESIN
    GOTTEX SUNGLASSES
    LENS SPECTACLE NON-CUSTOM (PRESCRIPTION)
    GIRARD SUNGLASSES (NON-PRESCRIPTION)
    ZIMLITE LENS
    SEIKO P-2 & SEIKO P-3 (SPECTACLE LENS)
    WRAPPERS, SUNGLASSES
    SPECTACLES LENS
    THE ULTRA-MATE LENS
    O.M.S. UV-COLOURS
    AURALITE II
    SPECTACLE PRESCRIPTION LENSES
    SUNGLASES
    CR-39 TYPE RESIN
    SUNGLASSES
    MULTIPLE LENS, SPECTACLES, CUSTOM
    MULTIPLE LENS, SPECTACLES CUSTOM
    CUSTOM LITE
    CRISTY/COTE
    SUNGLASSES
    MULTIPLE
    NOSITE UV INTERIM SPECTACLES
    SUNGLASS LENSES
    CORNING CPF 550 LENS
    SUNGLASSES
    DI-CROWN
    PHOTOLITE AOLITE TINTOMATIC LENS
    BARNES-HIND SPECTACLE LENS CLEANER
    BLENDED BIFOCAL
    POSTOPERATIVE UV GLASSES (PLANO/APHAKIC)
    THE LENS OR OMMI-GARD
    BARNES-HIND WETTING & SOAKING SOLUTION
    ULTRAVUE BLENDED BIFOCAL LENS
    FUL-VUE ASPHERIC CATARACT LENS
    LENS, POLYCORE
    HUMAN II LENS

    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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