Cleared Traditional

Profoject? Disposable Syringe, Profoject? Disposable Syringe with Needle

K252033 · CMT Health PTE., Ltd. · General Hospital
Jul 2025
Decision
25d
Days
Class 2
Risk

About This 510(k) Submission

K252033 is an FDA 510(k) clearance for the Profoject? Disposable Syringe, Profoject? Disposable Syringe with Needle, 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 July 25, 2025, 25 days after receiving the submission on June 30, 2025. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number K252033 FDA.gov
FDA Decision Cleared SESE
Date Received June 30, 2025
Decision Date July 25, 2025
Days to Decision 25 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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