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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: PNR FDA class 2

    Enteral Syringes With Enteral Specific Connectors

    Gastroenterology, Urology

    View full classification →

    The Enteral Syringes With Enteral Specific Connectors (product code PNR) are Class 2 gastroenterology and urology devices used to deliver nutrition, medication, or hydration orally or to a gastrointestinal tube or extension set using AAMI/CN3(PS):2014 compliant connectors, regulated under 876.5980. They require 510(k) clearance and are designed to reduce misconnection risks through enteral-specific connector standards. The devices are not implants and are not life-sustaining.

    510(k) Clearances

    33 matches
    K Number
    Device Name
    Monoject™ Enteral Syringe with ENFit Connector (401SE); Monoject™ Enteral Syringe with ENFit Connector (403SE); Monoject™ Enteral Syringe with ENFit Connector (406SE); Monoject™ Enteral Syringe with ENFit Connector (412SE); Monoject™ Enteral Syringe with ENFit Connector (435SE); Monoject™ Enteral Syringe with ENFit Connector (460SE)
    Nutricair Enteral Syringe with ENFit
    Oral/Enteral Syringe with ENFit connector
    Single Use O-ring gasket syringe with ENFit Connector, Reusable O-ring gasket syringe with ENFit connector
    ENFit enteral syringes (NUTRIFIT)
    Enteral Pump Syringe
    ENFit Reusable Enteral Syringe
    Oral/Enteral Syringe with ENFit connector
    ENFit Disposable Enteral Syringe
    Oral/Enteral Syringe
    Medline ENfit OTC Feeding Syringe
    Enteral Feeding Syringes with ENfit connector (Model: 10 ml; 60 ml control ring)
    Disposable Enteral Feeding Syringe with Enfit Connector
    Oral/Enteral Syringe
    ENFit Oral / Enteral Syringe
    Oral/Enteral Syringes with ENFit connector (12 mL to 60 mL), Low Dose Tip Oral/Enteral Syringes with ENFit connector (1 mL to 6 mL)
    Enteral Feeding Syringes with Enfit Connectors
    Oral/Enteral Syringe (10 mL to 60 mL) and Low Dose Tip Oral/Enteral Syringe (1 mL to 5 mL)
    AMSure® Enteral Feeding Syringe with ENFit Tip
    DASH 3 ENFit Syringe, DASH 3 Eccentric ENFit Syringe, DASH 3 Plus ENFit Syringe, DASH 3 Plus Eccentric ENFit Syringe, DASH 3 ENFit Low Dose Tip Syringe
    Tamper Evident Cap For use with ENFit Syringes
    ENFit enteral syringe
    ENFit Enteral Pump Syringes PENTA ENFit, ENFit Enteral Pump Syringes NUTRIFIT
    Medela Low Dose Enteral Syringe
    U&U Enteral Syringe
    Enteral Syringe with ENFit Connector (10 ml to 60 ml), Enteral Syringe with ENFit Low Dose Tip (1 ml to 5 ml)
    Monoject Enteral Syringe with ENFit Connector
    NeoConnect Oral/Enteral Syringes with ENFit connector (12 mL to 100 mL) and NeoConnect Low Dose Tip Oral/Enteral Syringes with ENFit connector (0.5 mL to 6mL)
    Monoject
    Monoject Enteral Feeding Syringe with ENFit Connector
    NeoMed NeoConnect Enteral Syringes with ENFit Connector and compatible NeoSecure Tip Caps
    NeoMed NeoConnect Enteral Syringes with ENFit Connector
    KANGAROO ENTERAL FEEDING SYRINGES WITH ENFIT CONNECTOR

    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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