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

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

    K Number: K252490 · Decision Feb 12, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    157
    Registration Numbers
    157
    Same Product Code
    109
    Applicant Total
    12
    Review Days
    188

    Basic Information

    Device Name
    Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV)
    K Number
    K252490
    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
    Tianjin Huahong Technology Co., Ltd.
    Date Received
    August 8, 2025
    Decision Date
    February 12, 2026
    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

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    Other Clearances by Tianjin Huahong Technology Co., Ltd.

    K Number Device Name
    K260191 Safety lancet (XXXVII)
    K253706 Lancing device (HH-XV-T)
    K251694 safety lancet
    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)
    K241627 Safety Lancet (XXXV)
    K240806 Safety lancet (XXVIII, XXIX, XXX, XXXI, XXXII, XXXIII, XXXIV.)
    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)
    K221176 Insulin Pen Needle
    K220370 Safety Lancet (XIII, XVII, XXI, XXII, XXIII, XXIV, XXV, XXVI)
    K220372 Heel Stick Safety Lancet (HHZ-II, HHZ-III)
    Search all 12 clearances from Tianjin Huahong Technology Co., Ltd. →