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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: MPA FDA class 2

    Endoilluminator

    Gastroenterology, Urology

    View full classification →

    The Endoilluminator is a surgical device used during vitreoretinal surgery that provides illumination inside the eye, enabling surgeons to visualize intraocular structures during procedures such as vitrectomy. Classified as FDA Class 2 under 21 CFR 876.1500 in the Gastroenterology and Urology specialty, it requires 510(k) premarket notification and is eligible for third-party review. The product code is MPA, reviewed by the Ophthalmic panel.

    510(k) Clearances

    40 matches
    K Number
    Device Name
    Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator (8065000253); Alcon 27+ DS Endoilluminator (8065000256);
    Midfield Light Pipe, 23ga (3269.M06-00); Midfield Light Pipe, 25ga (3269.M05-00); Midfield Light Pipe, 27ga (3269.M04-00)
    ITrack Advance Canaloplasty Microcatheter with Advanced Delivery System
    Nam illumination probe with chopper
    23ga Chandelier Illuminator, 25ga Chandelier Illuminator
    Synergetics PHOTON EX
    ISCIENCE INTERVENTIONAL OPHTHALMIC MICROCATHETER
    XENON BRIGHTSTAR ILLUMINATION SYSTEM, MODEL 1266.XIII
    ISCIENCE SURGICAL FIBEROPTIC ILLUMINATOR, MODEL FI - 100
    ISCIENCE SURGICAL OPHTHALMIC MICROCANNULA
    SYNERGETICS SYNERLIGHT FIBER OPTIC LIGHTSOURCE
    INSIGHT 4000 ENDOSCOPE
    TRANSPAK (VITREORETINAL INFUSION PAK), MODELS 90000, 90001
    PEREGRINE FIBER OPTIC MULTI-FUNCTION MANIPULATOR
    PEREGRINE FIBER OPTIC BIPOLAR STRAIGHT PICK AND ANGLED PICK, MODELS PD100.12 AND PD100.13
    PEREGRINE TAPERED DIFFUSION PROBE
    PEREGRINE SHIELDED DIFFUSION PROBE
    D.O.R.C. HEXON ILLUMINATION SYSTEM
    SYNTEC TRUE LIGHT END IRRIGATING ENDOILLUMINATOR
    SYNTEC TRUE LIGHT ENDOILLUMIINATOR WITH PICK
    D.O.R.C. SOLUX LIGHT SOURCE
    I-SCOPE OPHTHALMIC ENDOSCOPE
    ENDOLIGHT END IRRIGATING ENDO-ILLUMINATOR (20 GA. AND 19 GA.)
    SYNERGETICS SYNERLIGHT FIBER OPTIC LIGHTSOURCE
    ENDOLIGHT FIBEROPTIC ENDO-ILLUMINATOR (20 GA. & 19 GA.)
    MBI CO-AXIAL ILLUMINATED RETINAL PICK
    MBI ILLUMINATED RETINAL PICK
    SYNTEC, INC. DISPOSABLE BARE END FIBER
    ENDOLIGHT FIBEROPTIC REGULAR MONOFILAMENT AND FINE MONOFILAMENT
    VITROTEC TRUE LIGHT ENDOILLUMINATOR (100-S)
    VITLITE (TR7700)
    MBI FIBEROPTIC ENDO-ILLUMINATOR
    STORZ MVS 1011A DISPOSABLE FIBEROPTIC ENDOILLUMINATOR
    GAMP & ASSOCIATES DISPOSABLE END IRRIGATING ENDOILLUMINATOR
    GAMP & ASSOCIATES DISPOSABLE FIBEROPTIC VISCOINJECTOR
    INFINITECH HIGH INTENSITY XENON LIGHT SOURCE SYSTEM
    INFINITECH LIGHTED INFUSION CANNULA
    GAMP & ASSOCIATES DISPOSABLE FIBEROPTIC ENDOILLUMINATOR
    GAMP & ASSOCIATES DISPOSABLE BARE END FIBER
    GAMP & ASSOCIATES DISPOSABLE ENDOILLUMINATOR W/PICK

    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.

    Popular Product Codes

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