Cleared Traditional

Profoject? Disposable Needle

K252631 · CMT Health PTE., Ltd. · General Hospital
Oct 2025
Decision
57d
Days
Class 2
Risk

About This 510(k) Submission

K252631 is an FDA 510(k) clearance for the Profoject? Disposable Needle, a Needle, Hypodermic, Single Lumen (Class II — Special Controls, product code FMI), submitted by CMT Health PTE., Ltd. (Gateway West, SG). The FDA issued a Cleared decision on October 16, 2025, 57 days after receiving the submission on August 20, 2025. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5570.

Submission Details

510(k) Number K252631 FDA.gov
FDA Decision Cleared SESE
Date Received August 20, 2025
Decision Date October 16, 2025
Days to Decision 57 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FMI — Needle, Hypodermic, Single Lumen
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5570

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