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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: KYZ FDA class 1

    Syringe, Irrigating (Non Dental)

    General Hospital

    View full classification →

    The Non-Dental Irrigating Syringe is a general-purpose medical syringe used to flush or irrigate wounds, body cavities, or tissue sites with fluid during clinical procedures, distinct from syringes intended for dental use. It is classified as FDA Class 1, the lowest risk category, subject to general controls only, and is exempt from Good Manufacturing Practice (GMP) requirements. The product code is KYZ, regulated under 21 CFR 880.6960, in the General Hospital medical specialty. This device is GMP exempt.

    510(k) Clearances

    41 matches
    K Number
    Device Name
    OtoSet- Ear Cleaning System
    SINGLE CANNULA EXTENDED APPLICATOR
    TISSU TRANS HARVEST TUBING
    TISSU-TRANS
    QS DELIVERY SYSTEM
    IRRIGATION SYRINGE KIT
    ZEROWET SPLASHIELD
    RMI DUAL FLUID IRRIGATING SYRINGE
    MARPP PRESSURE MONITORING SYSTEM
    CPR IRRIGATION TRAY
    REDI NURSE SYSTEM (RNS) PRE-FILLED 10CC, 30CC, 60CC SYRINGE W/STERILE WATER
    REDI NURSE SYSTEM (RNS) PRE-FILLED 60CC IRRIGATION SYRINGE W/STERILE SODIUM CHLORIDE SOLUTION
    INMAN IRRIGATION TAPERED PROBE
    SURGICAL SEALANT APPLICATOR TIP ENDOSCOPIC TIP
    TALC DISPENSER SYRINGE
    AVITENE DISPENSER SYRINGE
    IRRIGATING BLUNT DISSECTOR
    WELCH ALLYN EARCLEANER
    IRRIGATION TRAY W/ BULB SYRINGE
    SPLASH GUARD
    INSTRUMENT MAKAR GRAVITY ASSIST SYSTEM
    IRRICLEAR EAR IRRIGATION SYRINGE
    ZEROWET SPLASHIELD
    GRAVITY ASSIST
    IRRIGATION TRAY
    STRYKER TRAUMA TRAY
    STERILE IRRIGATION TRAYS
    EAR IRRIGATION SET 101 (EARIGATOR)
    JOHNSON & JOHNSON STERILE SPRAY TIP SYRINGE
    IRRIGATION KIT
    SURGICAL SEALANT APPLICATOR
    SURGICAL SEALANT DISPENSER (SSD)
    CLEAN-FLUSH
    SYRINGE IRRIGATING
    STERILE IRRIGATING SYRINGES, KITS,TRAY
    SYRINGE, ENT
    IRRIJET
    IRRIGATION SET W/BULB SYRINGE
    SAPCRILL THERMODETECT BREAST SCANNER DEV
    60CC IRRIGATING SYRINGE, PISTON TYPE,
    IRRIGATION CAP

    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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