FDA 510(k)

Profoject™ Pen Needles (Model A; Model B)

N.º K: K260739 · 2026-07-15

Fecha de decisión2026-07-15

Código de productoFMI

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Profoject™ Pen Needles (Model A; Model B) 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 2026-07-15 under 510(k) number K260739. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Profoject™ Pen Needles (Model A; Model B)?

Profoject™ Pen Needles (Model A; Model B) is a medical device that received FDA 510(k) clearance on 2026-07-15. The listed applicant is CMT Health PTE., Ltd.. The 510(k) number is K260739.

When did Profoject™ Pen Needles (Model A; Model B) receive FDA 510(k) clearance?

Las agujas de pen Profoject™ (Modelo A; Modelo B) recibieron la aprobación FDA 510(k) el 15 de julio de 2026, bajo el número de 510(k) K260739.

Who is the listed applicant for Profoject™ Pen Needles (Model A; Model B)?

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™ Pen Needles (Model A; Model B)?

The FDA product code for Profoject™ Pen Needles (Model A; Model B) is FMI.

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Otros registros que enlistan a CMT Health PTE., Ltd. como solicitante

K262215Profoject™ Safety Sliding Blood Collection Set K261372Profoject™ LOR Syringe K261829Profoject™ Dual-Safety Pen Needles K260514Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety Needle K260855Profoject™ Safety Pen Needles K253268Profoject Enteral/Oral Feeding Syringe; Profoject Reusable Enteral/Oral Feeding Syringe (Model A, Model B); Profoject ENFit Adaptor; Profoject Enteral Feeding Syringes Cap

Ver todos los 12 dispositivos →

Dispositivos relacionados (Código: 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.K260855Profoject™ Safety Pen NeedlesCMT Health PTE., Ltd.

Fuente oficial

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