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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: HJK FDA class 2

    Lens, Contact, Polymethylmethacrylate, Diagnostic

    Ophthalmic

    View full classification →

    The Polymethylmethacrylate (PMMA) Diagnostic Contact Lens is a rigid, optically clear contact lens temporarily placed on the eye to facilitate detailed biomicroscopic or goniosopic examination of anterior or posterior ocular structures. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket clearance before marketing. The product code is HJK, regulated under 21 CFR 886.1385, within the Ophthalmic medical specialty. This device is eligible for third-party 510(k) review by an FDA-accredited reviewer.

    510(k) Clearances

    41 matches
    K Number
    Device Name
    RxSight Contact Lens
    Endocular Viewing Lenses and Silicone Ring
    Volk Disposable Iridotomy Lens, Volk Disposable Capsulotomy Lens
    Sensor Medical Family of Vitrectomy Lenses and Products
    SUPER VIEW DISPOSABLE BIOM LENS SET
    HAAG-STREIT CONTACT GLASSES STERY CUP, ACCESSORY
    VOLK DISPOSABLE VITRECTOMY LENSES, MODELS VOLK FLAT SSV D, VOLK AFX SSV D, VOLK 45 PRISM SSV D
    DORC VITRECTOMY LENSES, MODEL 1284 SERIES
    DISPOSABLE VITRECTOMY SETS, DISPOSABLE VIRECTOMY LENSES
    CONTACT LASER & DIAGNOSTIC LENSES
    LUNEAU 3 MIRROR LENS
    STAURENGHI WIDE FIELD SCANNING LASER LENS
    DISPOSABLE VITRECTOMY LENS
    ENDOVIEW SPPHIRE LENS SET
    MANDELKORN SUTURE LYSIS LENS
    RITCH NYLON SUTURE LASER LENS
    VIRECTOMY LENS
    QUADRASPHERIC FUNDUS LENS
    50 DEGREE HRI PRISM LENS
    PEDIATRIC VITRECTOMY LENS SET
    LANDERS HIGH REFRACTIVE INDEX VITRECTOMY LENS SET
    MAINSTER HIGH MAGNIFICATION LASER LENS
    NMR-K FUNDUS LASER LENS
    MAINSTER WIDE FIELD LASER LENS
    WOLDOFF PRISMATIC BICONCAVE LENS
    HOSKINS-BARKAN GONIOTOMY LENS 10MM
    BICONCAVE VITRECTOMY LENS
    HOSKINS-BARKAN GONIOTOMY LENS 9MM
    PEYMAN G. 12.12 YAG LASER LENS
    18MM PEYMAN WIDE FIELD YAG LASER LENS
    12.5MM PEYMAN WIDE FIELD YAG LASER LENS
    25MM PEYMAN WIDE FIELD YAG LASER LENS
    YANNUZZI FUNDUS LASER LENS
    MAINSTER RETINA LASER LENS
    LANDERS INDIRECT VITRECTOMY LENS
    HOSKINS NYLON SUTURE LASER LENS
    SCHIRMER PERIPHERAL IRIDECTOMY LASER LENS
    ABRAHAM YAG LASER LENS
    LENS-EZE
    WISE IRIDOTOMY-SPINCTEROTOMY LENS
    SURGICAL EYE SHIELD

    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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