K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB)

The K-Pack Embrace™ Active Safety Needle is a hypodermic needle with a manually activated hinged safety shield used to inject or withdraw fluids from subcutaneous body locations. After use, the healthcare provider manually presses the safety shield over the needle to minimize accidental needlestick injury risk. It is compatible with standard luer slip and luer lock syringes and comes in two gauges (25G at 5/8" and 1" lengths).

The subject device differs from the predicate in three respects: (1) hub and shield materials switched from polypropylene to polycarbonate; (2) adhesive changed from epoxy to acrylic (UV-cured); (3) packaging changed from hard blister pack to hard plastic cap/case design. The cannula (stainless steel), lubricant (silicone oil), sterilization method (EO to 10⁻⁶ SAL), and 5-year shelf life remain identical. The subject device covers two needle specifications versus the predicate's two different specifications.

ISO 7864:2016, ISO 9626:2016, ISO 80369-7:2021, ISO 6009:2016, ISO 23908:2011, ISO 11607-1:2019, ISO 11607-2:2019, ISO 10993-1:2018, ISO 10993-17, ISO 10993-18, ISO 11135:2014, EN 556-1:2024, USP <788>, ASTM F1980.

The predicate device (SurGuard 3) and subject device perform identical indications for use with manual safety shield activation. Although materials differ (polycarbonate hub/shield instead of polypropylene, acrylic adhesive instead of epoxy, and hard-pack instead of blister-pack), these changes do not introduce new safety or effectiveness questions because: (1) all material changes undergo identical biocompatibility testing per ISO 10993-1; (2) both devices meet the same performance standards (ISO 7864, 9626, 80369-7); and (3) packaging validation uses the same ISO 11607 standards. The technological differences are minor and do not alter the device's fundamental function, safety profile, or user interaction.