BEUDAMED
    Product Code: QRL FDA class 2 21 CFR 878.4850

    Multiple Use Blood Lancet For Single Patient Use Only

    General, Plastic Surgery

    The Multiple Use Blood Lancet for Single Patient Use Only is a blood sampling device consisting of a single-use blade on a solid, reusable base, intended to puncture the skin to obtain a blood drop for diagnostic testing, with the base designed for repeated use by a single patient only. It differs from purely single-use lancets in that the base unit can be used across multiple lancing events for the same patient. Classified as FDA Class 2 under regulation 878.4850, it requires 510(k) clearance in the General and Plastic Surgery specialty. The device is not an implant and not life-sustaining.

    View on FDA
    510(k)s
    24
    FEI Numbers
    84
    Registration Numbers
    84
    Unique Applicants
    18
    Years Active
    4

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    Basic Information

    Product Code
    QRL
    Device Class
    FDA class 2
    Regulation Number
    878.4850
    Medical Specialty
    General, Plastic Surgery
    Review Panel
    SU
    Submission Type
    1

    Device Characteristics

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

    Definition

    A multiple use capable blood lancet intended for use on a single patient 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.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 24 510(k) clearances via K numbers.

    K Number Device Name
    K253706 Lancing device (HH-XV-T)
    K250813 MICROLET®NEXT 2 Lancing Device
    K243306 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)
    K232912 Facet Aurora Reusable Lancet Base
    K231797 Medifun Lancing Device, Model No. LD-E1
    K223643 Verifine® Ease Lancing Device, Verifine® Lancing Device
    K221419 TD-5010 Lancing Device and TD-5084 Sterile Lancets
    K222472 Lancing System, Sterile Lancet for Single Use, Lancing Device
    K223099 Facet Manatee Reusable Lancing Base
    K222656 LDE4 Lancing Device
    K222246 Disposable Sterile Lancet
    K222539 Facet Blood Lancets
    K221072 TRUEdraw Lancing Device, Mini Lancing Device
    K221175 Multi-Lancet Device 2, ReliOn Premier Lancing Device
    K221613 Freestyle Lancing Device II, Autolet, Autolet Lite, Unilet Lancets
    K221062 RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing Device
    K222034 RightLance Blood Lancing System
    K221970 Lancing device
    K221546 OneTouch Delica Plus Lancing System
    K220387 Disposable Blood Lancets
    K220475 Lancet (I, II, III, V, VI); Lancing device (HH-X-T, HH-XIII-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)
    K220633 MICROLET NEXT lancing device, MICROLET Lancet
    K220608 Accu-Chek FastClix Blood Lancing System
    K214022 Accu-Chek Softclix Blood Lancing System

    FEI Numbers

    This FDA classification entry is associated with 84 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 84 registration numbers. Click on an entry to view related FDA registrations.