BEUDAMED
    Product Code: QRM FDA class 3 21 CFR 878.4850

    Multiple Use Blood Lancet For Multiple Patient Use

    General, Plastic Surgery

    The Multiple Use Blood Lancet for Multiple Patient Use is a blood-sampling lancet with a reusable base and single-use blades that is intended for use across multiple patients, which introduces significantly elevated infection and cross-contamination risks compared to single-patient devices. Due to this elevated risk profile, it is classified as FDA Class 3 under regulation 878.4850, requiring Premarket Approval (PMA) and falling under the General and Plastic Surgery specialty. This classification reflects the heightened safety concerns of multi-patient reuse. The device is not an implant and not life-sustaining.

    View on FDA
    510(k)s
    0
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    0
    Years Active
    —

    Research product code QRM in seconds

    The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Product Code
    QRM
    Device Class
    FDA class 3
    Regulation Number
    878.4850
    Medical Specialty
    General, Plastic Surgery
    Review Panel
    SU
    Submission Type
    2

    Device Characteristics

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

    Definition

    A multiple use capable blood lancet intended for use on multiple patients that is comprised of a single use blade attached to a solid, reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.