BEUDAMED
    Product Code: QOI FDA class 2 21 CFR 880.5220

    Intravenous Catheter Force-Activated Separation Device.

    General Hospital

    The Intravenous Catheter Force-Activated Separation Device is placed inline with an IV catheter and an intravascular administration set; it separates into two parts when a specified force is applied, intended to reduce the risk of IV catheter failures requiring replacement by providing a controlled breakaway point. This device is classified as FDA Class 2, requiring 510(k) clearance, under regulation 880.5220 in the General Hospital specialty. It carries product code QOI and is not an implant and not life-sustaining.

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    510(k)s
    8
    FEI Numbers
    6
    Registration Numbers
    6
    Unique Applicants
    5
    Years Active
    3

    Basic Information

    Product Code
    QOI
    Device Class
    FDA class 2
    Regulation Number
    880.5220
    Medical Specialty
    General Hospital
    Review Panel
    HO
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    An intravenous (IV) catheter force-activated separation device. An intravenous catheter force-activated separation device is placed inline with an intravenous catheter and an intravascular administration set, including any administration set accessories. It separates into two parts when a specified force is applied. The device is intended to reduce the risk of IV catheter failure(s) requiring IV catheter replacement.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 8 510(k) clearances via K numbers.

    K Number Device Name
    K241415 Orchid Safety Release Valve™
    K232094 Orchid Safety Release ValveTM
    K231957 SafeBreak® Vascular
    K223486 SafeBreak® Vascular
    K230266 Orchid Safety Release Valve
    K222791 SafeBreak Vascular
    K212064 Orchid Safety Release Valve(TM)
    DEN190043 SafeBreak Vascular

    FEI Numbers

    This FDA classification entry is associated with 6 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.