BEUDAMED
    Product Code: QRK FDA class 2 21 CFR 878.4850

    Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature

    General, Plastic Surgery

    The Single Use Only Blood Lancet Without an Integral Sharps Injury Prevention Feature is a disposable lancet comprised of a single-use blade attached to a solid, non-reusable base, used to puncture the skin and obtain a drop of blood for in vitro diagnostic purposes. It is designed for single-patient, single-use application without a safety mechanism to prevent needlestick injury. Classified as FDA Class 2 under regulation 878.4850, it requires 510(k) clearance and falls under the General and Plastic Surgery specialty. The device is not an implant and not life-sustaining.

    View on FDA
    510(k)s
    16
    FEI Numbers
    82
    Registration Numbers
    82
    Unique Applicants
    12
    Years Active
    4

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    Basic Information

    Product Code
    QRK
    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 disposable blood lancet intended for a single use that is comprised of a single use blade attached to a solid, nonreusable 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 16 510(k) clearances via K numbers.

    K Number Device Name
    K261634 Disposable Blood Lancet (Soft)
    K250016 droplet® personal lancets
    K244031 Disposable Blood Lancet (Soft Pro); Disposable Blood Lancet (Softsure); Disposable Blood Lancet (Softsure Pro); Disposable Blood Lancet (Softsense)
    K242622 Sterile Lancets for Single Use
    K241810 MICROLET®NEXT Lancet
    K232330 Lancing System
    K230712 SG Lanset I, SG Lancets, Soft Lancets
    K230310 STAT Medical Device Lancing System
    K230759 SafeLan® (2 models/SafeLan 26G, SafeLan 30G), SafeLan®-Pro (1 model/SafeLan®-Pro)
    K222617 EasyTouch Lancing Device
    K223815 ONE DROP Lancing Device
    K223314 Disposable Blood Lancets
    K223480 Medipoint Blood Lancets
    K221383 MedtFine Blood Lancet
    K221507 Disposable Blood Lancet
    K221433 Facet 28G Universal Lancet

    FEI Numbers

    This FDA classification entry is associated with 82 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 82 registration numbers. Click on an entry to view related FDA registrations.