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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: HNR FDA class 1

    Forceps, Ophthalmic

    Ophthalmic

    View full classification →

    Ophthalmic Forceps are surgical grasping instruments used in eye surgery to handle, position, and manipulate delicate ocular tissues and structures, including the cornea, iris, lens capsule, sutures, and foreign bodies. This device is FDA Class 1 (lowest risk), subject only to general controls without requiring premarket notification or approval. It carries product code HNR and is regulated under 21 CFR 886.4350, within the Ophthalmic medical specialty.

    510(k) Clearances

    44 matches
    K Number
    Device Name
    STEPHENS DISPOSABLE FORCEPS
    ALCON FOLDING FORCEPS
    SOFT LENS FOLDING BLOCK
    PHACO-INJECTOR(TM) INTRAOCULAR LENS IMPLANT INSTR
    MCDONALD FOLDING FORCEPS
    BRADBURY INTRAOCULAR RETINAL KIT CAT #200
    IOL IMPLANTATION FORCEPS
    ADVANCED SURGICAL PRODUCTS SCLERAL PLUG FORCEPS
    OPHTHALMIC SURGICAL INSTRUMENTS
    OPHTHALMIC KNIFE & FORCEPS
    FAULKNER FORCEPS
    FIXATION INSTRUMENTS
    THORTON TITANIUM NEEDLEHOLDERS(NO,W CATCH & STAND
    THORNTON TITANIUM FORCEPS (VARIOUS TYPES)
    PACO-FOLDER (TM) INTRAOCULAR LENS FORCEPS
    MANUAL OPHTHALMIC SURGICAL INSTRUMENTS
    MANUAL OPHTHALMIC SURGICAL INSTRUMENTS
    STORZ/MAZZACCO LENS FORCEP
    INTRAOCULAR FORCEPS & SCISSORS
    ASCON SURGICAL INSTRUMENTS
    37-610 TO 37-880 VARIOUS OPHTHAL-FORCEPS
    37-940 TO 37-944 VARIOUS NOYES OPHTHALMIC FORCEPS
    PHARMASEAL EYE PREP TRAY
    SHURE GRIP TYING FORCEPS
    CILCOR OPHTHALMIC INSTRUMENTS
    ROOTMAN ORBITAL SURGERY INSTRUMENT SET
    MICRO FORCEPS
    MICROSURGICAL INSTRUMENTS
    ANIS LENS IMPLANT FORCEPS #2
    FISHER-PICKERING INTRAOCULAR EYE MAGNET
    DODICK LENS HOLDING FORCEPS
    GASKIN FRAGMENT FORCEPS(MFG. NON-STERILE
    OPHTHALMIC FORCEPS
    FIX. & LENS FOR. #'S 3510,3512,3248,3795
    LIEBERMAN POLACK DOUBLE CORNEAL FORCEPS
    SHEPARD LENS FORCEP W/ IRRIGATOR & LOCK
    SHEPARD II, LENS FORCEP W/ LOCK
    SHEPARD LENS FORCEP W/ IRRIGA W/OUT LOCK
    HERSHMAN LENS FORCEPS WITH IRRIGATOR
    HERSHMAN LENS FORCEPS W/OUT IRRIGATOR
    BINKHORST LENS FORCEP W/ IRRIGATOR
    BINKHORST LENS FORCEPS W/OUT IRRIGATOR
    WECK TYING FORCEP, CURVED TITANIUM
    WECK TYING FORCEP, STRAIGHT TITANIUM

    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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