Profoject Insulin Syringes; Profoject Safelock Disposable Insulin Syringe
K-Number: K253068 · 2026-02-23
ApplicantCMT Health PTE., Ltd.
Decision Date2026-02-23
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Profoject Insulin Syringes; Profoject Safelock Disposable Insulin Syringe is a medical device manufactured by CMT Health PTE., Ltd.. It received FDA 510(k) clearance on 2026-02-23 under approval 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. It is manufactured by CMT Health PTE., Ltd.. The 510(k) number is K253068.
When was Profoject Insulin Syringes; Profoject Safelock Disposable Insulin Syringe approved by the FDA?
Profoject Insulin Syringes; Profoject Safelock Disposable Insulin Syringe received FDA 510(k) clearance on 2026-02-23, under approval number K253068.
What company makes Profoject Insulin Syringes; Profoject Safelock Disposable Insulin Syringe?
Profoject Insulin Syringes; Profoject Safelock Disposable Insulin Syringe is manufactured by CMT Health PTE., Ltd..
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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Other Devices by CMT Health PTE., Ltd.
K252631Profoject Disposable Needle
K252033Profoject Disposable Syringe, Profoject Disposable Syringe with Needle
K251585Profoject Enteral Feeding Syringe
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
Related Devices (Code: FMF)
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K162602NovoPen EchoNovo Nordisk, Inc.
K161568Bone Solutions Mixing and Delivery SystemBone Solutions, Inc.
K152879Sure-Fine Insulin SyringesShina Med Corporation
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.