BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    MICROLET®NEXT 2 Lancing Device

    K Number: K250813 · Decision May 14, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    84
    Registration Numbers
    84
    Same Product Code
    23
    Applicant Total
    7
    Review Days
    58

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    Basic Information

    Device Name
    MICROLET®NEXT 2 Lancing Device
    K Number
    K250813
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4850
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ascensia Diabetes Care U.S., Inc.
    Date Received
    March 17, 2025
    Decision Date
    May 14, 2025
    Product Code
    QRL
    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
    QRL Multiple Use Blood Lancet For Single Patient Use Only

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (QRL), ordered by most recent decision date.

    Lancing device (HH-XV-T)

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    Lancet (IA, IB, IC, ID, IE, IK, IL, IM, IIA, IIB, III, V, VI, VII, VIII, IX); Lancing device (HH-X-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T, HH-XXV-T, HH-XXVI-T, HH-XXVIII-T, HH-XXIX-T, HH-XXX-T, HH-XIII-T, HH-XXVII-T)

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    Other Clearances by Ascensia Diabetes Care U.S., Inc.

    K Number Device Name
    K241787 CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System
    K241810 MICROLET®NEXT Lancet
    K223293 CONTOUR® NEXT GEN Blood Glucose Monitoring System
    K220633 MICROLET NEXT lancing device, MICROLET Lancet
    K162336 Contour Next EZ Blood Glucose Monitoring System
    K160430 Contour Next Link Wireless Blood Glucose Monitoring System, Contour Next Blood Glucose Monitoring System