Cleared Traditional

K142745 - 125mL CT Syringe

K142745 is an FDA 510(k) clearance for 125mL CT Syringe, manufactured by Coeur, Inc.. The device is a Class 2 Cardiovascular device with product code DXT cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K142745 · Coeur, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2015
Decision
189d
Days
Class 2
Risk

K142745 is an FDA 510(k) clearance for the 125mL CT Syringe. Classified as Injector And Syringe, Angiographic (product code DXT), Class II - Special Controls.

Submitted by Coeur, Inc. (Lebanon, US). The FDA issued a Cleared decision on April 1, 2015 after a review of 189 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.

FDA 510(k) Submission Details - K142745

510(k) Number K142745 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2014
Decision Date April 01, 2015
Days to Decision 189 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
64d slower than avg
Panel avg: 125d · This submission: 189d
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 183
Devices cleared under the same product code (DXT) and FDA review panel - the closest regulatory comparables to K142745.
Dyevert Contrast Modulation System
K151746 · Osprey Medical, Inc. · Oct 2015
AVERT Contrast Modulation System
K152218 · Osprey Medical · Sep 2015
MRXperion MR Injection System, MRXperion MR Injection System Syringe Kit
K143538 · Bayer Medical Care, Inc. · Aug 2015
AVERT Contrast Modulation System
K150485 · Osprey Medical, Inc. · Mar 2015
CONTRAST MONITORING SYSTEM DISPLAY, CONTRAST MONITORING SYSTEM SYRINGES
K142081 · Osprey Medical, Inc. · Dec 2014
MR SYRINGE DUAL PACK
K140469 · Coeur, Inc. · Jul 2014