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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: KNT FDA class 2

    Tubes, Gastrointestinal (And Accessories)

    Gastroenterology, Urology

    View full classification →

    Gastrointestinal Tubes and Accessories are devices inserted through the mouth, nose, or stoma into the gastrointestinal tract for purposes including enteral feeding, gastric drainage, decompression, and medication delivery in patients unable to take nutrition or medications orally. It is classified as FDA Class 2, indicating moderate risk requiring 510(k) premarket clearance. The product code is KNT and the applicable regulation is 21 CFR 876.5980 in the Gastroenterology and Urology specialty.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    XNY Disposable Gastric Calibration Tube
    Flexi-Seal AIR (with ENFit Connector)
    hygh-tec Drainage II
    ZZIREN™ Orogastric Tube; ZZIREN™ SGT Orogastric Tube - 32 Fr (ZZ-SGT-32); ZZIREN™ SGT Orogastric Tube - 36 Fr (ZZ-SGT-36); ZZIREN™ SGT Orogastric Tube - 40 Fr (ZZ-SGT-40); ZZIREN™ GBT Orogastric Tube - 32 Fr (ZZ-GBT-32); ZZIREN™ GBT Orogastric Tube - 36 Fr (ZZ-GBT-36); ZZIREN™ GBT Orogastric Tube - 40 Fr (ZZ-GBT-40)
    Entarik NI Feeding Tube System
    CORGRIP* SR NG/NI Tube Retention System
    CORTRAK* 2 Enteral Access System (20-0950)
    Stylus
    ReShape Calibration Tubes (B-2032, B-2036, B-2040); ReShape Calibration Tubes (B-2017); Gastric Balloon Suction Catheter (B-2020)
    ViSiGi LUX (5332); ViSiGi LUX (5336); ViSiGi LUX (5340)
    Enteral Feeding Sets
    Endolumik Gastric Calibration Tube M Series (EGCT36M); Endolumik Gastric Calibration Tube M Series (EGCT40M)
    ViSiGi 3D Gastric Sizing Tube
    AMT G-Tube Balloon Gastrostomy Feeding Device
    Entarik Feeding Tube System; Entarik Feeding Tube
    Endolumik Fluorescence Guided Gastric Calibration Tube (FG Bougie)
    ReShape Calibration Tubes
    hygh-tec drainage
    Standard Tapered Bougie, 38 Fr.
    DoubleChek DC-1001
    Gastrointestinal Boundary Identifier (GIBI HD)
    Gastric Lightguide (GLG)
    Lap-Band System Calibration Tube
    Siren SGT
    Avanos* CORTRAK* 2 Enteral Access System (EAS)
    Qora Stool Management Kit
    Standard Bougie, 38 Fr. and Hand Pump
    Standard Bougie, 38 Fr.
    Safety Trocar Cannula
    Enteral Feeding Catheter
    ENvizion Medical ENvue ENvizion Medical Enteral Feeding Tube
    TubeClear System
    Nutriglide(TM) Nasal Feeding Tube
    Entuit Nasal Jejunal Feeding Tube
    Standard Bougie
    Avantgarde Faecal Management Systems, Avantgarde Faecal Management System Replacement Pouches
    Navina Smart System, Navina Classic System
    McLean-Ring Enteral Feeding Tube Set
    ENvizion Medical ENVue SYSTEM, ENvizion Medical Enteral Feeding Tube
    CORTRAK* 2 Equilateral Enteral Access System
    Entuit PEG, Entuit PEGJ
    Medline Quick-Clear Wand
    Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector)
    Micro Transgastric-Jejunal Feeding Device
    Traditional Length GJ Feeding Device
    ENvizion Medical ENvue; ENvizion Medical Enteral Feeding Tube
    Aspire Venting Tube
    GastroFlush
    Kangaroo Gastrostomy Feeding Tube with ENFit Y-Port
    Aspire Introducer Needle

    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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