Cleared Abbreviated

K182216 - Merit Syringe

K182216 is the FDA 510(k) clearance for Merit Syringe by Merit Medical Systems, Inc.. It is a Class 2 General Hospital device (product code FMF) cleared through the Abbreviated 510(k) pathway after a 83-day FDA review.

K182216 · Merit Medical Systems, Inc. · General Hospital
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Nov 2018
Decision
83d
Days
Class 2
Risk

K182216 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 6, 2018 after a review of 83 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - the FDA general hospital device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Merit Medical Systems, Inc. devices

Submission Details

510(k) Number K182216 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 2018
Decision Date November 06, 2018
Days to Decision 83 days
Submission Type Abbreviated
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
46d faster than avg
Panel avg: 129d · This submission: 83d
Pathway characteristics
Standards-based clearance path.

Device Classification

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 285
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K182216.
BD Plastipak Syringe
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Orbit Subretinal Delivery System
K182274 · Orbit Biomedical, Inc. · Nov 2018
Merit Syringe
K182279 · Merit Medical Systems, Inc. · Nov 2018
BD Single Use, Hypodermic Syringe
K172670 · Becton, Dickinson and Company · Oct 2018
Graftgun Universal Graft Delivery System
K180937 · SurGenTec, LLC · May 2018