Cleared Traditional

K163054 - DyeVert Plus Contrast Modulation/Monitoring System, Contrast Monitoring System

K163054 is an FDA 510(k) clearance for DyeVert Plus Contrast Modulation/Monito..., 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 127-day FDA review.

K163054 · Osprey Medical, Inc. · Cardiovascular device
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Mar 2017
Decision
127d
Days
Class 2
Risk

K163054 is an FDA 510(k) clearance for the DyeVert Plus Contrast Modulation/Monitoring System, Contrast Monitoring 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 8, 2017 after a review of 127 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 - K163054

510(k) Number K163054 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 2016
Decision Date March 08, 2017
Days to Decision 127 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
2d slower than avg
Panel avg: 125d · This submission: 127d
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 K163054.
Smart Syringe
K171698 · Osprey Medical, Inc. · Jul 2017
Merit Coronary Control Syringe
K163084 · Merit Medical Systems, Inc. · Jun 2017
DyeVert Plus Contrast Reduction System, DyeVert NG Contrast Reduction System
K171217 · Osprey Medical, Inc. · May 2017
Ecomed Disposable Angiographic Syringes
K162088 · Ecomed Solutions, LLC · Jan 2017
Disposable High Pressure Injector Syringe
K152906 · Wuxi Yushou Medical Appliances Co., Ltd. · Nov 2016
Sunmed Control Syringes
K160190 · Sunny Medical Device (Shenzhen) Co., Ltd. · Nov 2016