Cleared Traditional

K924116 - MEDRAD MCT, MCT PLUS INJECTOR/MEDRAD FRONT LOAD

K924116 is an FDA 510(k) clearance for MEDRAD MCT, manufactured by Medrad, Inc.. The device is a Class 2 Cardiovascular device with product code DXT cleared through the Traditional 510(k) pathway after a 160-day FDA review.

K924116 · Medrad, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1993
Decision
160d
Days
Class 2
Risk

K924116 is an FDA 510(k) clearance for the MEDRAD MCT, MCT PLUS INJECTOR/MEDRAD FRONT LOAD. Classified as Injector And Syringe, Angiographic (product code DXT), Class II - Special Controls.

Submitted by Medrad, Inc. (Pittsburgh, US). The FDA issued a Cleared decision on January 21, 1993 after a review of 160 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 Medrad, Inc. devices

FDA 510(k) Submission Details - K924116

510(k) Number K924116 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 1992
Decision Date January 21, 1993
Days to Decision 160 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
35d slower than avg
Panel avg: 125d · This submission: 160d
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 169
Devices cleared under the same product code (DXT) and FDA review panel - the closest regulatory comparables to K924116.
MEDRAD ENVISION CT INJECTOR AND QWIK FIT SYRINGE
K934086 · Medrad, Inc. · Jun 1995
MEDRAD CT CUSTOM CONVENIENCE KIT
K933908 · Medrad, Inc. · Feb 1994
CAVERNOSOMETRY MODULE FOR MENUET
K923117 · Dantec Medical, Inc. · Feb 1993
MEDRAD MCT-PLUS INJECTOR
K913624 · Medrad, Inc. · Jul 1992
CT 8000 DIGITAL INJECTION SYSTEM
K912944 · Mallinckrodt Group, Inc. · Feb 1992
TRAC-WRIGHT SYSTEM, MODEL TW2
K910594 · Dow Corning Wright · Sep 1991