Cleared Traditional

K140425 - CONTRAST MODULATION SYSTEM

K140425 is an FDA 510(k) clearance for CONTRAST MODULATION SYSTEM, manufactured by Osprey Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DXT cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K140425 · Osprey Medical, Inc. · Cardiovascular device
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Jun 2014
Decision
112d
Days
Class 2
Risk

K140425 is an FDA 510(k) clearance for the 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 June 11, 2014 after a review of 112 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Osprey Medical, Inc. devices

FDA 510(k) Submission Details - K140425

510(k) Number K140425 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 2014
Decision Date June 11, 2014
Days to Decision 112 days
Submission Type Traditional
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
13d faster than avg
Panel avg: 125d · This submission: 112d
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 164
Devices cleared under the same product code (DXT) and FDA review panel - the closest regulatory comparables to K140425.
CONTRAST MONITORING SYSTEM DISPLAY, CONTRAST MONITORING SYSTEM SYRINGES
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DUAL SHOT ALPHA 7
K133189 · Nemoto Kyorindo Co., Ltd. · Jun 2014
COEUR, INC. FRONTLOAD FOR OPTIVANTAGE POWER INJECTOR
K133600 · Coeur, Inc. · Apr 2014
MEDRAD MARK 7 ARTERION INJECTION SYSTEM / SYRINGE, TWIST & GO SYRINGE
K132928 · Medrad, Inc. / Bayer Medical Care, Inc. · Jan 2014
CONTRAST CONSERVATION SYSTEM
K131478 · Osprey Medical, Inc. · Aug 2013