Cleared Special

K181936 - DyeVert PLUS EZ Contrast Reduction System

K181936 is the FDA 510(k) clearance for DyeVert PLUS EZ Contrast Reduction System by Osprey Medical, Inc.. It is a Class 2 Cardiovascular device (product code DXT) cleared through the Special 510(k) pathway after a 98-day FDA review.

K181936 · Osprey Medical, Inc. · Cardiovascular device
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Oct 2018
Decision
98d
Days
Class 2
Risk

K181936 is an FDA 510(k) clearance for the DyeVert PLUS EZ Contrast Reduction 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 October 25, 2018 after a review of 98 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. 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. Standard predicate reliance. 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

Submission Details

510(k) Number K181936 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 2018
Decision Date October 25, 2018
Days to Decision 98 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
27d faster than avg
Panel avg: 125d · This submission: 98d
Pathway characteristics
Modification to existing cleared device.

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 101
Devices cleared under the same product code (DXT) and FDA review panel - the closest regulatory comparables to K181936.
DyeVert™ NG Contrast Reduction System, DyeVert™ PLUS EZ Contrast Reduction System, DyeTect™ Contrast Monitoring Disposable Kit, Smart Syringe, DyeVert™ PLUS EZ Contrast Reduction System
K183267 · Osprey Medical, Inc. · Dec 2018
MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX Syringe Kits, MEDRAD Stellant CT Injection System with Certegra Workstation, MEDRAD Stellant Syringe Kits, MEDRAD Stellant Connector Tubing, P3T Cardiac, P3T PA, P3T Abdomen, ISI, Connect.CT
K182273 · Bayer Medical Care, Inc. · Nov 2018
MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit
K182276 · Bayer Medical Care, Inc. · Nov 2018
Sterile High-pressure Angiographic Syringes for Single-use
K182289 · Shenzhen Baoan Medical Supplies Co., Ltd. · Oct 2018
MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX Syringe Kits, MEDRAD Stellant CT Injection System with Certegra Workstation, MEDRAD Stellant Syringe Kits, MEDRAD Stellant Connector Tubing, P3T Cardiac, P3T PA, P3T Abdomen, ISI, Connect.CT
K173773 · Bayer Medical Care, Inc. · Aug 2018
Sterile Disposable Syringes
K172694 · Shenyang Mastech Medical Device Co., Ltd. · Jul 2018