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510(k) Data Aggregation

    K Number
    K253605

    Validate with FDA (Live)

    Date Cleared
    2026-02-20

    (94 days)

    Product Code
    Regulation Number
    878.4850
    Age Range
    0 - 1
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Safety Heel Lancet is a single use device with a sterile blade that is used by medical professionals to obtain a blood sample from the heel of neonates and infants.

    Device Description

    Safety Heel Lancet, could be divided into Model D and Model E according to the shape of the trigger lock. The difference of Model D and Model E is that trigger lock of Model D doesn't need to be broke before use, trigger lock of Model E need to be broke before use. Safety Heel Lancet is composed of housing, trigger lock, trigger button, blade, blade holder, slider, side cover and spring. The material of blade is X65Cr13 stainless steel, the material of spring is 304 stainless steel, the other plastic parts are ABS. The blade is ejected and retracted by a mechanical structure to realize blood sampling. There is an integrated automatic inactivation system of the device to prevent device reuse. After the protection system is activated, the blade will be permanently retracted into the housing and cannot be restored to the activated state to avoid accidental injury to personnel. Therefore, the device cannot be re-used. It has sharps injury protection feature that it can reduce the occurrence of accidental needlesticks. Safety Heel Lancet is sterilized by Gamma ray(e-beam) and for single use. It is designed to be used by medical professionals to obtain a blood sample from the heel of neonates and infants. Safety Heel Lancet is sterile and non-toxic. The device is intended for prescription (Rx) only.

    AI/ML Overview

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