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510(k) Data Aggregation

    K Number
    K253622

    Validate with FDA (Live)

    Date Cleared
    2026-03-18

    (120 days)

    Product Code
    Regulation Number
    880.5570
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Safety pen needle is intended for use with pen injector devices for subcutaneous injection of drugs. It has sharps protection feature of the patient-end and cartridge-end. For Model SD, the needle tube tip is 3 bevel. For Model SDW, the needle tube tip is 5 bevel.

    Device Description

    Safety Pen Needle, could be divided into Model SD and Model SDW.
    Model SD/SDW consists of needle hub,shield sleeve,rear spring,front spring, slider, inner shell,protective jacket,needle tube,outer container and seal(dialysis paper).

    Safety Pen Needle,could be divided into two models according to the needle tube tip is 3 or 5 bevel; the needle tube is thin-wall. Although the product of different model have different needle tube tip, but the same is that a double-ended needle tube is fixed with needle hub, the needle tip is protected by a protective jacket, the product is sealed with medical dialysis paper and needle container. The device is sterilized by EO gas and for single use. The shelf life is 5 years. The device is non-toxic and non-pyrogenic.

    Needle tube is fixed in the center of the needle hub with UV glue, the needle tip is protected with protective jacket before use, medical dialysis paper is covered and sealed needle container to maintain sterile of the device. The cartridge end of needle can be inserted into the rubber of insulin pen, meanwhile the needle hub is connected to insulin pen with screw thread to provide sterile fluid path for injection of insulin during use. The patient end and the cartridge end of the needle tube are lubricated with silicone oil for ease of injection and rubber penetration.

    Safety Pen Needle has sharps injury protection feature that it can reduce the occurrence of accidental needlesticks from the patient end and cartridge end of the needle due to the effect of safe-lock guard.

    AI/ML Overview

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