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510(k) Data Aggregation

    K Number
    K252490

    Validate with FDA (Live)

    Device Name
    Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV)
    Manufacturer
    Tianjin Huahong Technology Co., Ltd.
    Date Cleared
    2026-02-12

    (188 days)

    Product Code
    FMK
    Regulation Number
    878.4850
    Type
    Special
    Panel
    General & Plastic Surgery
    Age Range
    0 - 3
    Reference & Predicate Devices
    K220372
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Heel Stick Safety Lancet is intended for the collection of capillary blood from the heel of newborn, preemie, and toddler. The lancet has equipped with safety protection features.

    Device Description

    The heel stick safety lancet is offered in various depth size (0.65mm, 0.85mm, 1.00mm, 1.50mm,1.8mm) and width size (1.50 mm, 1.75mm, 2.50 mm, 2.80 mm, 3.0 mm).

    It consists of blade base, blade, which is welded with the blade base, spring, top head, bottom, and pushing button. The top head and bottom are intended to provide physical protection to the blade, and PET blister along with the tyvek paper cover the primary sterile barrier system for the device. The product is individually primarily packaged and sterilized to a SAL of 10-6 by radiation sterilization. It is intended for single use only. The shelf-life of the product is 5 years.

    AI/ML Overview

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