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

    MedtFine Safety Lancet

    K Number: K241848 · Decision Aug 20, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    157
    Registration Numbers
    157
    Same Product Code
    109
    Applicant Total
    2
    Review Days
    54

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    MedtFine Safety Lancet
    K Number
    K241848
    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
    Ningbo Caremed Medical Products Co., Ltd.
    Date Received
    June 27, 2024
    Decision Date
    August 20, 2024
    Product Code
    FMK
    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
    FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature

    Similar 510(k) Clearances

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

    Verifine Safety Lancets

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Safety lancet (XXXVII)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Safety Heel Lancet

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    safety lancet

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Heel Incision Safety Lancet (SteriHeel 2)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery
    View all

    Other Clearances by Ningbo Caremed Medical Products Co., Ltd.

    K Number Device Name
    K242622 Sterile Lancets for Single Use