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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: LNS FDA class 2

    Lithotriptor, Extracorporeal Shock-Wave, Urological

    Gastroenterology, Urology

    View full classification →

    Lithotriptor, Extracorporeal Shock-Wave, Urological is a device that generates focused high-energy shock waves directed from outside the body to fragment kidney stones or other urinary tract calculi into smaller pieces that can be passed naturally, used as a non-invasive alternative to surgical stone removal. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket clearance. The product code is LNS, regulated under 21 CFR 876.5990, within the Gastroenterology/Urology medical specialty. No special flags apply to this device.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Extracorporeal Shock Wave Lithotripter (U200)
    Delta III Pro
    LM-9300 Plus Lithotripter
    Modulith SLX-F2
    Delta III Lithotripter
    Delta III Lithotripter
    Delta III Lithotripter
    Gemini XXP-HP
    LM-9300 ELMA Lithotripter
    EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER
    EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER, COMED ASADAL-M1
    EXTRA CORPOREAL SHOCKWAVE LITHOTRIPTER
    EXTRA CORPOREAL SHOCKWAVE LITHOTRIPTER
    GEMINI LITHOTRIPTER
    MODULTH SLK
    DUET MAGNA
    LITE-MED LM-9200 ELMA
    SONOLITH I-MOVE
    EM-9000
    SONOLITH I-SYS LITHOTRIPER
    PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPTER
    LITHOSKOP
    STORZ MODULITH LITHOTRIPTER SLX-F2-F180
    MODULARIS VARIOSTAR
    STORZ SLX-F2 STORM TOUCH
    ECONOLITH EM1000
    LITHODIAMOND ULTRA
    LITHOGOLD
    INTEGRA SL
    INTEGRA
    TRIPTER-X1 COMPACT DUET SP (SEPARATED PULSE)
    GENESTONE EXEL (XL) EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER
    TWINHEADS TH-103 EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER
    STORZ MODULITH, MODEL SLX-F2
    ULTRASOUND LOCALIZATION SYSTEM ULS 0142
    MODIFICATION TO TRIPTER X-1 COMPACT DUET
    ECONOLITH E3000, MODEL 3000 (SW-6)
    TRIPTER X-1 COMPACT
    PIEZOLITH 3000 LITHOTRIPTER, MODEL 3000
    TWINHEADS TH-101 EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER
    TRIPTER X-1 COMPACT DUET
    LTFS230
    MODULITH SLK LITHOTRIPTER
    DELTA 2000 SERIES EXTRACORPOREAL LITHOTRIPTER
    STONELITH, MODEL V5
    TWINTRODE ELC 134 ELECTRODE
    STORZ MODULITH SLK LITHOTRIPTER WITH MULTIVIEW OPTION
    DORNIER LITHOTRIPTER S(DOLI S) & DORNIER LITHOTRIPTER S-XP (DOLI S-XP)
    DORNIER LITHOTRIPTER 140(DOLI 140)
    MPS M ELECTRODE

    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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