BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇸🇬 Singapore

    Profoject™ Enteral Feeding Syringe

    K Number: K251585 · Decision Jul 18, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    51
    Registration Numbers
    51
    Same Product Code
    32
    Applicant Total
    8
    Review Days
    56

    Basic Information

    Device Name
    Profoject™ Enteral Feeding Syringe
    K Number
    K251585
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5980
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    CMT Health PTE., Ltd.
    Date Received
    May 23, 2025
    Decision Date
    July 18, 2025
    Product Code
    PNR
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    PNR Enteral Syringes With Enteral Specific Connectors

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    Other Clearances by CMT Health PTE., Ltd.

    K Number Device Name
    K260514 Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety Needle
    K260855 Profoject™ Safety Pen Needles
    K253268 Profoject Enteral/Oral Feeding Syringe; Profoject Reusable Enteral/Oral Feeding Syringe (Model A, Model B); Profoject ENFit Adaptor; Profoject Enteral Feeding Syringes Cap
    K253068 Profoject™ Insulin Syringes; Profoject™ Safelock Disposable Insulin Syringe
    K252814 Profoject™ Low Dead Space Syringe /Profoject™ Tuberculin Syringe; Profoject™ Low Dead Space Syringe with Needle /Profoject™ Tuberculin Syringe with Needle; Profoject™ Low Dead Space Syringe with Permanent Needle /Profoject™ Tuberculin Syringe with Permanent Needle; Profoject™ Low Dead Space Safety Syringe /Profoject™ Tuberculin Safety Syringe
    K252631 Profoject™ Disposable Needle
    K252033 Profoject™ Disposable Syringe, Profoject™ Disposable Syringe with Needle