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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: KNQ FDA class 2

    Dilator, Esophageal

    Gastroenterology, Urology

    View full classification →

    An Esophageal Dilator is a medical device used in gastroenterology to dilate narrowed or strictured regions of the esophagus, restoring luminal patency in patients with esophageal strictures, achalasia, or dysphagia caused by benign or post-procedural narrowing. It is classified as FDA Class 2, indicating moderate risk requiring 510(k) premarket notification. The product code is KNQ and it is regulated under 21 CFR 876.5365 in the Gastroenterology and Urology specialty.

    510(k) Clearances

    40 matches
    K Number
    Device Name
    CRE FIXED WIRE BALLON DILATION CATHETER
    ETHICON ENDO-SURGERYOPTICAL DILATOR
    HERCULES 3 STAGE WIRE GUIDED DILATION BALLOON
    SMART DILATOR
    COOK ENDOSCOPY ESOPHAGEAL DILATION BALLOON
    MAXFORCE TTS SINGLE-USE BALLOON DILATOR
    INSCOPE PRECISION BALLOON DILATOR - WIRE GUIDED
    INSCOPE 3-STAGE BALLOON DILATOR
    BARD ELIMINATOR PET BALLOON DILATORS
    OPTICAL DVS (DUAL VECTOR SHEARING) ESOPHAGEAL DILATOR
    CORDIS MAXI LD LARGE DIAMETER BALLOON DILATATION CATHETER, CORDIS MAXI LD PTA BALLOON DILATION CATHETER
    MEDOVATIONS ESOPHAGEAL DILATOR
    CORDIS MAXI LD LARGE DIAMETER BALLOON DILATATION CATHETER
    IMPACT BALLOON DILATION CATHETER
    JACKSON ESOPHAGEAL DILATOR
    CRE(TM) BALLOON DILATATION CATHETER
    CRE BALLOON DILATATION CATHETER
    PATTISON ESOPHAGEAL DILATOR
    BALLON DILATATION CATHETER
    XXL BALLOON DILATATION CATHETER
    OVER THE GUIDEWIRE DILATATION SYSTEM
    WILSON-COOK BALLOON INFLATION DEVICE
    MICROVASIVE MAXFORCE
    TRI-MED INFLATABLE ESOPHAGEAL DILATOR
    OLYMPUS SCLEROTHERAPY BALLOON
    FLEX-TECH BALLOON DILATOR
    WILSON-COOK BALLOON DILATION CATHETERS
    ESOPHAGEAL BALLOON DILATOR
    ACHELASIA BALLOON DIALATOR
    ESOPHAGEAL AND PYLORIC BALLOON DIALATORS
    PORGES STEPPED NEOPLEX DILATOR
    MODIFIED KEYMED FLEXIBLE ESOPHAGEAL DILATORS
    KEYMED FLEXIBLE ESOPHAGEAL DILATORS
    AMERICAN DILATATION SYSTEM
    SAVARY-GILLIARD DILATOR
    GASTROINTESTINAL DILATOR
    COAXIAL BALLOON GASTROESOPHAGEAL DILA
    ESOPHAGEAL BOUGIES
    TRI-DILS-TRIPLE OLIVE-ESOPHAGEAL DILATOR
    CELESTIN DILATOR

    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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