Cleared Traditional

K190102 - DyeVert Plus Contrast Reduction System

K190102 is the FDA 510(k) clearance for DyeVert Plus Contrast Reduction System by Osprey Medical, Inc.. It is a Class 2 General Hospital device (product code DXT) cleared through the Traditional 510(k) pathway after a 268-day FDA review.

K190102 · Osprey Medical, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2019
Decision
268d
Days
Class 2
Risk

K190102 is an FDA 510(k) clearance for the DyeVert™ Plus Contrast Reduction System, DyeTect™ 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 October 17, 2019 after a review of 268 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 870.1650 - the FDA general hospital device 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Osprey Medical, Inc. devices

Submission Details

510(k) Number K190102 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 2019
Decision Date October 17, 2019
Days to Decision 268 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
139d slower than avg
Panel avg: 129d · This submission: 268d
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 General Hospital 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 K190102.
Sterile High-pressure Angiographic Syringes for Single-use
K192657 · Shenzhen Boon Medical Supply Co., Ltd. · Aug 2020
MEDRAD Stellant FLEX CT Injection System with Certegra Workstation
K192370 · Bayer Medical Care, Inc. · Dec 2019
MEDRAD Mark 7 Arterion Injection System
K193028 · Bayer Medical Care, Inc. · Dec 2019
ACIST CVI1 Contrast Delivery System, A1000 Syringe Kit, A1000V Syringe Kit, BT2000 Manifold Kit, BT2000 Manifold Kit, AngioToiuch Hand Controller Kit
K191060 · Acist Medical Systems, Inc. · Jul 2019
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