Cleared Traditional

Profoject? Insulin Syringes; Profoject? Safelock Disposable Insulin Syringe

K253068 · CMT Health PTE., Ltd. · General Hospital
Feb 2026
Decision
154d
Days
Class 2
Risk

About This 510(k) Submission

K253068 is an FDA 510(k) clearance for the Profoject? Insulin Syringes; Profoject? Safelock Disposable Insulin Syringe, a Syringe, Piston (Class II — Special Controls, product code FMF), submitted by CMT Health PTE., Ltd. (Singapore, SG). The FDA issued a Cleared decision on February 23, 2026, 154 days after receiving the submission on September 22, 2025. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number K253068 FDA.gov
FDA Decision Cleared SESE
Date Received September 22, 2025
Decision Date February 23, 2026
Days to Decision 154 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FMF — Syringe, Piston
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5860

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