Cleared Traditional

K163054 - DyeVert Plus Contrast Modulation/Monito...

K163054 is the FDA 510(k) clearance for DyeVert Plus Contrast Modulation/Monito... by Osprey Medical, Inc.. It is a Class 2 Cardiovascular device (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

Submission Details

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
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.

Device Classification

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 102
Devices cleared under the same product code (DXT) and FDA review panel - the closest regulatory comparables to K163054.
ACISTCVi® Contrast Delivery System
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DiamondTOUCH Inflation Device and Fluid Dispensing Syringe
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DeRoyal Angiography Kits
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MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM), (TABLE MOUNT SYSTEM), MEDRAD MARK 7 ARTERION ARTERION SYRINGE
K113133 · Medrad, Inc. · Dec 2011