510(k) K251447

K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB) by Terumo Europe N.V. — Product Code FMI

K251447 is an FDA 510(k) premarket notification submitted by Terumo Europe N.V. for the device "K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB)". The FDA issued a decision of Substantially Equivalent on July 8, 2025. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Terumo Europe N.V. has at least 10 other 510(k) clearances on record.