BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Disposable Blood Lancet (Soft)

    K Number: K261634 · Decision Jun 12, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    82
    Registration Numbers
    82
    Same Product Code
    15
    Applicant Total
    9
    Review Days
    25

    Basic Information

    Device Name
    Disposable Blood Lancet (Soft)
    K Number
    K261634
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.4850
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    SteriLance Medical (Suzhou), Inc.
    Date Received
    May 18, 2026
    Decision Date
    June 12, 2026
    Product Code
    QRK
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    QRK Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature

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