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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: KMJ FDA class 1

    Lubricant, Patient

    General Hospital

    View full classification →

    Patient Lubricant is a medical-grade topical lubricant used in clinical settings to facilitate the insertion or passage of medical devices such as catheters, specula, and endoscopes, reducing friction and patient discomfort during procedures. It is classified as FDA Class 1, indicating low risk subject to general controls only, with no premarket clearance required. The product code is KMJ and the applicable regulation is 21 CFR 880.6375 in the General Hospital specialty.

    510(k) Clearances

    49 matches
    K Number
    Device Name
    Lubricating Jelly
    COLONGLIDE LUBRICANT
    COLONGLIDE(R) LUBRICANT
    LUBE JELLY SURINGE
    DUKAL LUBRICATING JELLY
    STERILE LUBRICATING JELLY
    DYNACOR LUBRICATION GEL
    ULTRA SEAL STERILE LUBRICATING JELLY
    DYNAREX STERILE LUBRICATING JELLY
    STERI-LUB LUBRICATION GEL
    SHEFFIELD PHARMACEUTICALS (STERILE) LUBRIGEL
    SPIRUS MEDICAL SURGICAL INSTRUMENT
    DUREX PLAY WARMER LUBRICANT
    E-Z LUBRICATING JELLY
    GOOD LUBRICATIONS
    PDI STERILE LUBRICATING JELLY
    LUBRIGLIDE
    LUBRICATING JELLY, LOW VISCOSITY
    EVRON GEL
    AQUAGEL LUBRICATING JELLY
    MAXILUBE
    STERI-LUB LUBRICATION GEL
    ASTROGLIDE
    COMFORT PERSONAL LUBRICANT
    OPERAND LUBRICATING JELLY
    MENTOR LUBRICATING JELLY
    LUBRICATING JELLY
    DISPENSA-LUBE
    OPERAND* LUBRICATING JELLY
    OSBON PERSONAL LUBRICANT
    OSBON PERSONAL LUBRICANT
    MODIFIED AMERICAN LUBRICATING JELLY, 2.7 & 5.0
    CONDOM-MATE VAGINAL LUBRICANT
    K-GEL
    AMERICAN LUBRICATING JELLY STERILE 2.7G & 5G
    LUBRICATING JELLY
    AQUALUBE(TM)
    STERILE SALINE SOLUTION
    SANA-LUBE
    TODAY PERSONAL LUBRICANT
    TOMAC LUBRICATING JELLY
    WET PACK LINE OF PRODUCTS
    A.D.T. PROCEDURES TRAY
    K-Y LUBRICATING JELLY
    PEDICAT*
    HYGENIC RUBBER DAM LUBRICANT
    LUBRICATING JELLY
    LUBRICANT, OTRHO PERSONAL
    PRESERVE LUBRICANT CODE NO. 43=4035

    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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