Hypodermic Needle-Pro EDGE Safety Device

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

510(k) Number

K211634 ↗

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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See all devices from Smiths Medical Asd, Inc. →

• What is the primary purpose of the Hypodermic Needle-Pro EDGE Safety Device, and how does it reduce risks for clinicians?

  The Hypodermic Needle-Pro EDGE Safety Device is designed to minimize the risk of needle-stick injuries during intravenous or subcutaneous procedures. It achieves this through an active safety mechanism that automatically retracts or covers the needle after use, protecting clinicians while still allowing for easy, single-handed engagement during the procedure.

• Is this device intended for reuse, or is it meant for single-use only? How is it packaged?

  The Hypodermic Needle-Pro EDGE Safety Device is explicitly intended for single-use only. It comes in sterile packaging, ensuring safety and hygiene for each procedure. The device is supplied in quantities of 100 needles per box, with 10 boxes per case, and is distributed exclusively in the US.

• What sizes are available for the Hypodermic Needle-Pro EDGE Safety Device, and how might this affect its clinical use?

  The Hypodermic Needle-Pro EDGE Safety Device is available in the 25G x 1½" gauge and length, which is commonly used for intravenous or subcutaneous injections. This size is versatile for a range of clinical procedures, including blood draws, medication administration, and fluid administration, making it suitable for hospitals and outpatient settings.

• How is the regulatory status of this device determined, and what does that mean for its use in clinical settings?

  The Hypodermic Needle-Pro EDGE Safety Device holds FDA 510(k) clearance under classification FMI, with a decision date of August 26, 2021. This clearance indicates that the device is deemed *substantially equivalent* to a legally marketed predicate device, meaning it meets FDA standards for safety and effectiveness. Clinicians can rely on this approval when selecting it for needle-stick injury prevention in procedures like IV or subcutaneous injections.

• What should clinicians consider regarding storage and distribution of this device?

  The device is distributed in the US in bulk quantities of 10 boxes per case, with each box containing 100 sterile, single-use needles. Clinicians should store it in a clean, dry environment away from direct sunlight or extreme temperatures to preserve sterility and functionality. The sterile packaging ensures readiness for immediate use in clinical settings like hospitals or outpatient care.