Cleared Special

Sure-Fine Insulin Syringes

K250510 · Shina Med Corporation · General Hospital
Oct 2025
Decision
236d
Days
Class 2
Risk

About This 510(k) Submission

K250510 is an FDA 510(k) clearance for the Sure-Fine Insulin Syringes, a Syringe, Piston (Class II — Special Controls, product code FMF), submitted by Shina Med Corporation (Anseong-Si, KR). The FDA issued a Cleared decision on October 15, 2025, 236 days after receiving the submission on February 21, 2025. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number K250510 FDA.gov
FDA Decision Cleared SESE
Date Received February 21, 2025
Decision Date October 15, 2025
Days to Decision 236 days
Submission Type Special
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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