FDA 510(k)

K-Pack Embrace Active 安全针（KNAS-2516RB，KNAS-2525RB）

K号: K251447 · 2025-07-08

决定日期2025-07-08

产品代码FMI

咨询委员会医疗设备监管文本翻译如下： HO 请注意，由于您没有提供具体的医疗设备监管文本内容，以上仅为示例。请提供具体的文本内容以便进行准确的翻译。

决定实质等同

器械摘要

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.

常见问题

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.

列明Terumo Europe N.V.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K24330927G x 1/2 TW K-Pack Surshield针头（KN-S2713RBT）K243581K-Pack Enhance 针（KH-2713RBBTC和KH-2913RBBTC）K230951Terumo 注射过滤器针 (NF-3013RBKE05M)K212095SurGuard3安全皮下注射针 K192057K-Pack II 针 - 27G x 1/2" 超薄壁，K-Pack II 针 - 27G x 1/2" 超薄壁，K-Pack II 针 - 30G x 1/2" 超薄壁，K-Pack II 针 - 30G x 1/2" 超薄壁 K161606带固定针头的注射器 - 仅用于 GONAL-F 多剂量 600 I/U mL FSH

查看所有 7 个设备 →

相关器械（代码：FMI）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K261266MOWANA™ 自动双联PENTAMASTER MEDIQ SDN BHD K261719Promisemed X 安全笔式针头Promisemed Hangzhou Meditech Co., Ltd.K262427注射针（普通型I类，安全型IIA，安全型IIB，安全型IIIA，安全型IIIB，安全型IV，安全型V，普通型VIA，普通型VIB，普通型VIC，安全型VII，普通型IB，安全型VIII，安全型IX，安全型X，普通型XI，安全型XII）Hh Global Technology, Inc.K260933安全无菌皮下注射针（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™ 双重安全笔式针头CMT Health PTE., Ltd.K260739Profoject™ 注射针（型号A；型号B）CMT Health PTE., Ltd.

官方来源

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