FDA 510(k)

Profoject™ Insulin Syringes; Profoject™ Safelock Disposable Insulin Syringe

Número K: K253068 · 2026-02-23

Data da decisão2026-02-23

Código do produtoFMF

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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Outros registros que listam CMT Health PTE., Ltd. como candidato(a)

K262215Profoject™ Safety Sliding Blood Collection Set K261372Profoject™ LOR Syringe K261829Profoject™ Dual-Safety Pen Needles K260739Profoject™ Pen Needles (Model A; Model B)K260514Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety Needle K260855Profoject™ Safety Pen Needles

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Dispositivos Relacionados (Código: FMF)

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 Safety Needle; Sol-Glide Safety Needle with SyringeSol-Millennium Medical, Inc.K260514Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety NeedleCMT Health PTE., Ltd.

Fonte oficial

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