Cleared Traditional

K152218 - AVERT Contrast Modulation System

Also marketed or referenced as:
AVERT Contrast Modulation System AVERT Contrast Modulation System

K152218 is an FDA 510(k) clearance for AVERT Contrast Modulation System, manufactured by Osprey Medical. The device is a Class 2 Cardiovascular device with product code DXT cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K152218 · Osprey Medical · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2015
Decision
45d
Days
Class 2
Risk

K152218 is an FDA 510(k) clearance for the AVERT Contrast Modulation System. Classified as Injector And Syringe, Angiographic (product code DXT), Class II - Special Controls.

Submitted by Osprey Medical (Minnetonka, US). The FDA issued a Cleared decision on September 21, 2015 after a review of 45 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1650 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Osprey Medical devices

FDA 510(k) Submission Details - K152218

510(k) Number K152218 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 2015
Decision Date September 21, 2015
Days to Decision 45 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 125d · This submission: 45d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXT Device Classification - Class 2, Special Controls

Product Code DXT Injector And Syringe, Angiographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1650
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DXT Injector And Syringe, Angiographic

All 119
Devices cleared under the same product code (DXT) and FDA review panel - the closest regulatory comparables to K152218.
Merit Coronary Control Syringe
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K152978 · Deroyal Industries, Inc. · Mar 2016
MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM), (TABLE MOUNT SYSTEM), MEDRAD MARK 7 ARTERION ARTERION SYRINGE
K113133 · Medrad, Inc. · Dec 2011
NMI CONTROL SYRINGE, 7 ML NMI CONTROL SYRINGE, 8 ML
K113198 · Navilyst Medical, Inc. · Nov 2011
MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM / TABLE MOUNT SYSTEM), MEDRAD MARK 7 ARTERION SYRINGE
K112086 · Medrad, Inc. · Oct 2011