FDA 510(k)

Profoject™ 胰岛素注射器；Profoject™ Safelock 一次性胰岛素注射器

K号: K253068 · 2026-02-23

决定日期2026-02-23

产品代码FMF

咨询委员会HO

决定Substantially Equivalent

器械摘要

Profoject™ Insulin Syringes; Profoject™ Safelock Disposable Insulin Syringe 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 2026-02-23 under 510(k) number K253068. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Profoject™ Insulin Syringes; Profoject™ Safelock Disposable Insulin Syringe?

Profoject™ Insulin Syringes; Profoject™ Safelock Disposable Insulin Syringe is a medical device that received FDA 510(k) clearance on 2026-02-23. The listed applicant is CMT Health PTE., Ltd.. The 510(k) number is K253068.

When did Profoject™ Insulin Syringes; Profoject™ Safelock Disposable Insulin Syringe receive FDA 510(k) clearance?

Profoject™ Insulin Syringes; Profoject™ Safelock Disposable Insulin Syringe received FDA 510(k) clearance on 2026-02-23, under 510(k) number K253068.

Who is the listed applicant for Profoject™ Insulin Syringes; Profoject™ Safelock Disposable Insulin Syringe?

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™ Insulin Syringes; Profoject™ Safelock Disposable Insulin Syringe?

The FDA product code for Profoject™ Insulin Syringes; Profoject™ Safelock Disposable Insulin Syringe is FMF.

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：FMF）

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。

K262581GraftGun Universal Graft Delivery System (GDS®)SurGenTec, LLC K252184SOL-M Luer Lock Syringe with Exchangeable Needle TraySol-Millennium Medical, Inc.K253747Disposable Pen Injector (KXYC-03C02, KXYC-03A03)Jiangsu Enjosim Medical Technology Co., Ltd.K260208Ultra-Fine™ SAFETY Insulin Syringeembecta Medical II, LLC K253110Sol-Glide安全针；带注射器的Sol-Glide安全针。Sol-Millennium Medical, Inc.K260514Profoject™ 安全针；Profoject™ 带安全针的注射器；Profoject™ 低死腔注射器带安全针CMT Health PTE., Ltd.

官方来源

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