Cleared Special

Merit Syringe

K250853 · Merit Medical Systems, Inc. · General Hospital
Nov 2025
Decision
228d
Days
Class 2
Risk

About This 510(k) Submission

K250853 is an FDA 510(k) clearance for the Merit Syringe, a Syringe, Piston (Class II — Special Controls, product code FMF), submitted by Merit Medical Systems, Inc. (South Jordan, US). The FDA issued a Cleared decision on November 4, 2025, 228 days after receiving the submission on March 21, 2025. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number K250853 FDA.gov
FDA Decision Cleared SESE
Date Received March 21, 2025
Decision Date November 04, 2025
Days to Decision 228 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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