FDA 510(k)

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

K-Number: K251447 · 2025-07-08

Decision Date2025-07-08

Product CodeFMI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB) is a medical device manufactured by Terumo Europe N.V.. It received FDA 510(k) clearance on 2025-07-08 under approval number K251447. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB)?

K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB) is a medical device that received FDA 510(k) clearance on 2025-07-08. It is manufactured by Terumo Europe N.V.. The 510(k) number is K251447.

When was K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB) approved by the FDA?

K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB) received FDA 510(k) clearance on 2025-07-08, under approval number K251447.

What company makes K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB)?

K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB) is manufactured by Terumo Europe N.V..

What is the FDA product code for K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB)?

The FDA product code for K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB) is FMI.

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Related PubMed Literature

PMID: 41477286 Comparison of the Safety and Efficacy of Biodegradable Microneedle Acupuncture and Sterile Acupuncture: study protocol for a prospective, confirmatory, superiority, multicenter, parallel, single-blinded randomized controlled trial. Journal of pharmacopuncture (2025) PMID: 40856794 [Translational challenges and clinical potential of artificial intelligence in minimally invasive surgery]. Chirurgie (Heidelberg, Germany) (2025) PMID: 40826904 Why we should be prioritizing the average treatment effect on the treated over other estimands when evaluating drug and device safety. American journal of epidemiology (2025)

Other Devices by Terumo Europe N.V.

K161606Syringe with fixed needle - For use only with GONAL-F Multi-Dose 600 I/U mL FSH K192057K-Pack II Needle - 27G x 1/2 Extra Thin Wall, K-Pack II Needle - 27G x 1/2 Ultra Thin Wall, K-Pack II Needle - 30G x 1/2 Extra Thin Wall, K-Pack II Needle - 30G x 1/2 Ultra Thin Wall K212095SurGuard3 Safety Hypodermic Needle K230951Terumo Injection Filter Needle (NF-3013RBKE05M) K24330927G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT) K243581K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC)

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Related Devices (Code: FMI)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.