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510(k) Data Aggregation

    K Number
    K234081
    Device Name
    RedDrop ONE (One)
    Manufacturer
    Date Cleared
    2024-03-21

    (90 days)

    Product Code
    Regulation Number
    878.4850
    Why did this record match?
    Applicant Name (Manufacturer) :

    RedDrop Dx

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The RedDrop ONE is a single-use blood lancing device intended for producing microliter capillary whole blood samples. It does not collect or transport such samples.
    Device Description
    The RedDrop ONE Lancet is a single-use blood lancing device with an integral sharps injury prevention feature intended for producing microliter capillary whole blood samples. The device is adhered to the skin in the selected position on the upper arm. The device is actuated by sliding the actuator causing an energized spring to release and deploy the lancet array. The lancet array is deployed to a maximum depth of 2 mm to access capillaries. The lancet array is then automatically retracted to a safe position that prevents sharps injury and re-activation. Sliding the actuator also releases two spring loaded pistons that create a gentle vacuum to the skin to facilitate the emergence of capillary blood from the sample site.
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