FDA 510(k)

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

Numéro K : K251447 · 2025-07-08

Date de décision2025-07-08

Code produitFMI

Comité consultatifHO

DécisionSubstantially Equivalent

Résumé du dispositif

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

Questions fréquentes

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. The listed applicant is Terumo Europe N.V.. The 510(k) number is K251447.

When did K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB) receive FDA 510(k) clearance?

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

Who is the listed applicant for K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB)?

The FDA 510(k) record lists Terumo Europe N.V. as the applicant. This does not by itself establish the device manufacturer.

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.

Essais cliniques associés

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Dispositifs connexes (Code : FMI)

K261266MOWANA™ Auto DuoPENTAMASTER MEDIQ SDN BHD K261719Promisemed X-Safety Pen NeedlePromisemed Hangzhou Meditech Co., Ltd.K262427Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety Type IIIB, Safety Type IV, Safety Type V, Ordinary Type VIA, Ordinary Type VIB, Ordinary Type VIC, Safety Type VII, Ordinary Type IB, Safety type VIII, Safety Type IX, Safety Type X, Ordinary Type XI, Safety Type XII)Hh Global Technology, Inc.K260933Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R, NR-S2016R, NR-S2025R, NR-S2038R, NR-S2051R, NR-S2116R, NR-S2125R, NR-S2138R, NR-S2151R, NR-S2216R, NR-S2225R, NR-S2238R, NR-S2251R, NR-S2316R, NR-S2325R, NR-S2338R, NR-S2351R, NR-S2516R, NR-S2525R, NR-S2538R, NR-S2551R, NR-S2516T, NR-S2525T, NR-S2538T, NR-S2551T)Hangzhou Qiantang Longyue Biotechnology Co., Ltd.K261829Profoject™ Dual-Safety Pen NeedlesCMT Health PTE., Ltd.K260739Profoject™ Pen Needles (Model A; Model B)CMT Health PTE., Ltd.

Source officielle

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