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

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K251447 ↗

FDA Product Code

FMI

Device Class

Class II

Regulation

21 CFR Part 880.5570

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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• What safety features does the K-Pack Embrace Active Safety Needle include to reduce the risk of needle-stick injuries?

  The K-Pack Embrace Active Safety Needle includes an active safety feature specifically designed to mitigate the risk of needle-stick injuries. This feature helps retract or secure the needle after use, reducing exposure to contaminated needles. The device is also classified under FDA product code FMI, which aligns with regulatory standards under 21CFR Section 880.5570 for hypodermic needles, ensuring compliance with safety-focused design controls.

• Are the K-Pack Embrace Active Safety Needles reusable or intended for single-use, and how should they be handled after use?

  The K-Pack Embrace Active Safety Needles are intended for single-use only, as specified for general hospital settings. Due to their active safety design, they are engineered to minimize reuse risks, but they should still be disposed of properly in a sharps container after use to prevent accidental injuries. The manufacturer emphasizes compliance with infection control protocols to ensure patient and clinician safety.

• What are the two reference codes available for the K-Pack Embrace Active Safety Needle, and how do they differ?

  The K-Pack Embrace Active Safety Needle is available in two reference codes: KNAS-2516RB and KNAS-2525RB. While the exact differences between these models are not detailed in the specifications, both share the same 6% Luer connection and active safety feature. The distinction likely relates to gauge size or length, which would determine their suitability for specific injection or withdrawal procedures. For precise application, refer to the manufacturer’s product documentation.

• How should the K-Pack Embrace Active Safety Needles be stored, and what sterility guarantees are provided?

  The K-Pack Embrace Active Safety Needles are supplied sterile, meaning they are packaged and sterilized to prevent contamination before use. Storage instructions are not explicitly detailed, but sterile medical devices like these typically require protection from moisture, extreme temperatures, and direct light. It’s recommended to store them in their original packaging in a clean, dry environment until use, following standard sterile supply chain protocols to maintain integrity.

• What regulatory pathway was followed for the FDA clearance of the K-Pack Embrace Active Safety Needle, and what does this mean for compliance?

  The K-Pack Embrace Active Safety Needle received FDA clearance through a traditional 510(k) process, classified as Substantially Equivalent (SESE) under product code FMI. This means the device meets FDA design control requirements and consensus standards, ensuring it complies with safety and performance expectations for hypodermic needles in hospital settings. The clearance was granted by the Hospital Devices (HO) Advisory Committee and is tied to the k-number K251447.