Cleared Traditional

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

K251447 · Terumo Europe N.V. · General Hospital
Jul 2025
Decision
60d
Days
Class 2
Risk

About This 510(k) Submission

K251447 is an FDA 510(k) clearance for the K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB), a Needle, Hypodermic, Single Lumen (Class II — Special Controls, product code FMI), submitted by Terumo Europe N.V. (Leuven, BE). The FDA issued a Cleared decision on July 8, 2025, 60 days after receiving the submission on May 9, 2025. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5570.

Submission Details

510(k) Number K251447 FDA.gov
FDA Decision Cleared SESE
Date Received May 09, 2025
Decision Date July 08, 2025
Days to Decision 60 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FMI — Needle, Hypodermic, Single Lumen
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5570

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