FDA 510(k)

Profoject™ 一次性针

K号: K252631 · 2025-10-16

决定日期2025-10-16

产品代码FMI

咨询委员会HO

决定Substantially Equivalent

器械摘要

Profoject™ Disposable Needle is the device name listed in this FDA 510(k) record. The listed applicant is CMT Health PTE., Ltd.. It received FDA 510(k) clearance on 2025-10-16 under 510(k) number K252631. 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 Profoject™ Disposable Needle?

Profoject™ Disposable Needle is a medical device that received FDA 510(k) clearance on 2025-10-16. The listed applicant is CMT Health PTE., Ltd.. The 510(k) number is K252631.

When did Profoject™ Disposable Needle receive FDA 510(k) clearance?

Profoject™ Disposable Needle received FDA 510(k) clearance on 2025-10-16, under 510(k) number K252631.

Who is the listed applicant for Profoject™ Disposable Needle?

The FDA 510(k) record lists CMT Health PTE., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Profoject™ Disposable Needle?

The FDA product code for Profoject™ Disposable Needle is FMI.

列明CMT Health PTE., Ltd.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。

K262215Profoject™ Safety Sliding Blood Collection Set K261372Profoject™ LOR Syringe K261829Profoject™ Dual-Safety Pen Needles K260739Profoject™ Pen Needles (Model A; Model B)K260514Profoject™ 安全针；Profoject™ 带安全针的注射器；Profoject™ 低死腔注射器带安全针 K260855Profoject™ 安全笔针

查看所有 12 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™ Auto DuoPENTAMASTER MEDIQ SDN BHD K261719Promisemed X 安全笔式针头Promisemed 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.

官方来源

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