Cleared Traditional

K143538 - MRXperion MR Injection System

K143538 is an FDA 510(k) clearance for MRXperion MR Injection System, manufactured by Bayer Medical Care, Inc.. The device is a Class 2 Cardiovascular device with product code DXT cleared through the Traditional 510(k) pathway after a 242-day FDA review.

K143538 · Bayer Medical Care, Inc. · Cardiovascular device
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Aug 2015
Decision
242d
Days
Class 2
Risk

K143538 is an FDA 510(k) clearance for the MRXperion MR Injection System, MRXperion MR Injection System Syringe Kit. Classified as Injector And Syringe, Angiographic (product code DXT), Class II - Special Controls.

Submitted by Bayer Medical Care, Inc. (Indianaola, US). The FDA issued a Cleared decision on August 14, 2015 after a review of 242 days - an extended review cycle.

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 Bayer Medical Care, Inc. devices

FDA 510(k) Submission Details - K143538

510(k) Number K143538 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 2014
Decision Date August 14, 2015
Days to Decision 242 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
117d slower than avg
Panel avg: 125d · This submission: 242d
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 111
Devices cleared under the same product code (DXT) and FDA review panel - the closest regulatory comparables to K143538.
Merit Coronary Control Syringe
K163084 · Merit Medical Systems, Inc. · Jun 2017
DiamondTOUCH Inflation Device and Fluid Dispensing Syringe
K160107 · Merit Medical Systems, Inc. · Jul 2016
DeRoyal Angiography Kits
K152978 · Deroyal Industries, Inc. · Mar 2016
MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM), (TABLE MOUNT SYSTEM), MEDRAD MARK 7 ARTERION ARTERION SYRINGE
K113133 · Medrad, Inc. · Dec 2011
NMI CONTROL SYRINGE, 7 ML NMI CONTROL SYRINGE, 8 ML
K113198 · Navilyst Medical, Inc. · Nov 2011
MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM / TABLE MOUNT SYSTEM), MEDRAD MARK 7 ARTERION SYRINGE
K112086 · Medrad, Inc. · Oct 2011