Cleared Special

K150485 - AVERT Contrast Modulation System

K150485 is an FDA 510(k) clearance for AVERT Contrast Modulation System, manufactured by Osprey Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DXT cleared through the Special 510(k) pathway after a 30-day FDA review.

K150485 · Osprey Medical, Inc. · Cardiovascular device
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Mar 2015
Decision
30d
Days
Class 2
Risk

K150485 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, Inc. (Minnetonka, US). The FDA issued a Cleared decision on March 26, 2015 after a review of 30 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. 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 Osprey Medical, Inc. devices

FDA 510(k) Submission Details - K150485

510(k) Number K150485 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 2015
Decision Date March 26, 2015
Days to Decision 30 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 125d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 164
Devices cleared under the same product code (DXT) and FDA review panel - the closest regulatory comparables to K150485.
AVERT Contrast Modulation System
K152218 · Osprey Medical · Sep 2015
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K143538 · Bayer Medical Care, Inc. · Aug 2015
125mL CT Syringe
K142745 · Coeur, Inc. · Apr 2015
CONTRAST MONITORING SYSTEM DISPLAY, CONTRAST MONITORING SYSTEM SYRINGES
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MR SYRINGE DUAL PACK
K140469 · Coeur, Inc. · Jul 2014
DUAL SHOT ALPHA 7
K133189 · Nemoto Kyorindo Co., Ltd. · Jun 2014