Cleared Special

K250853 - Merit Syringe

K250853 is an FDA 510(k) clearance for Merit Syringe, manufactured by Merit Medical Systems, Inc.. The device is a Class 2 General Hospital device with product code FMF cleared through the Special 510(k) pathway after a 228-day FDA review.

K250853 · Merit Medical Systems, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2025
Decision
228d
Days
Class 2
Risk

K250853 is an FDA 510(k) clearance for the Merit Syringe. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Merit Medical Systems, Inc. (South Jordan, US). The FDA issued a Cleared decision on November 4, 2025 after a review of 228 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K250853

510(k) Number K250853 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
99d slower than avg
Panel avg: 129d · This submission: 228d
Pathway characteristics
Modification to existing cleared device.

FMF Device Classification - Class 2, Special Controls

Product Code FMF Syringe, Piston
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5860
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FMF Syringe, Piston

All 755
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K250853.
DuoprossTM Smart Cap (Type I)
K252518 · Duopross Meditech Corporate · Dec 2025
EXEL Disposable Syringe
K251089 · Exelint International, Co. · Dec 2025
Verisafe Safety Retractable Insulin Syringes
K250192 · Promisemed Hangzhou Meditech Co., Ltd. · Dec 2025
Sure-Fine Insulin Syringes
K250510 · Shina Med Corporation · Oct 2025
Monoject™ 1mL Tuberculin Syringe Luer-Lock Tip (1180100777)
K243660 · Cardinalhealth · Aug 2025
BD Plastipak™ Syringe
K251350 · Becton, Dickinson and Company · Jul 2025
K250853 · Merit Syringe
Download PDF FDA Summary Merit Medical Systems…