FDA 510(k)

Profoject™ Insulin Syringes; Profoject™ Safelock Disposable Insulin Syringe

K-Number: K253068 · 2026-02-23

Decision Date2026-02-23

Product CodeFMF

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Other records listing CMT Health PTE., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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 K253268Profoject Enteral/Oral Feeding Syringe; Profoject Reusable Enteral/Oral Feeding Syringe (Model A, Model B); Profoject ENFit Adaptor; Profoject Enteral Feeding Syringes Cap K252814Profoject™ Low Dead Space Syringe /Profoject™ Tuberculin Syringe; Profoject™ Low Dead Space Syringe with Needle /Profoject™ Tuberculin Syringe with Needle; Profoject™ Low Dead Space Syringe with Permanent Needle /Profoject™ Tuberculin Syringe with Permanent Needle; Profoject™ Low Dead Space Safety Syringe /Profoject™ Tuberculin Safety Syringe

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Related Devices (Code: FMF)

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.K253112Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe)Hlb Lifescience Co., Ltd.K252279Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml)Chirana T.Injecta,A.S.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.