Cleared Special

K152783 - Merit 20 mL Syringe

K152783 is the FDA 510(k) clearance for Merit 20 mL Syringe by Merit Medical Systems, Inc.. It is a Class 2 General Hospital device (product code FMF) cleared through the Special 510(k) pathway after a 73-day FDA review.

K152783 · Merit Medical Systems, Inc. · General Hospital
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Dec 2015
Decision
73d
Days
Class 2
Risk

K152783 is an FDA 510(k) clearance for the Merit 20 mL 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 December 7, 2015 after a review of 73 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. 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Merit Medical Systems, Inc. devices

Submission Details

510(k) Number K152783 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2015
Decision Date December 07, 2015
Days to Decision 73 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
56d faster than avg
Panel avg: 129d · This submission: 73d
Pathway characteristics
Modification to existing cleared device.

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 249
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K152783.
BD 1ml Luer-lok Hypodermic Syringe, BD 1 mL Luer-Lok Hypodermic Syringe with BD Hypodermic Needle or BD Eclipse Hypodermic Needle, BD 1ml Luer-lok Insulin Syringe
K162081 · Becton, Dickinson and Company · Dec 2016
BD U-500 INSULIN SYRINGE
K151870 · Becton, Dickinson and Company · Jul 2016
LITe BIO Delivery System
K160978 · Stryker Corporation · Jul 2016
BD Single Use, Hypodermic Syringe
K151766 · Becton, Dickinson and Company · Sep 2015
ConMed Mixing and Delivery Kit
K142535 · Conmed Corporation · Apr 2015
Merit 10mL Syringe
K142636 · Merit Medical Systems, Inc. · Oct 2014