Cleared Special

MEDRAD STELLANT CT INJECTOR SYSTEM WITH IMAGING SYSTEM INTERFACE MODULE (K033881) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K033881 · Medrad, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2004
Decision
78d
Days
Class 2
Risk

K033881 is an FDA 510(k) clearance for the MEDRAD STELLANT CT INJECTOR SYSTEM WITH IMAGING SYSTEM INTERFACE MODULE. Classified as Injector And Syringe, Angiographic (product code DXT), Class II - Special Controls.

Submitted by Medrad, Inc. (Indianola, US). The FDA issued a Cleared decision on March 2, 2004 after a review of 78 days - a notably fast clearance cycle.

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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Medrad, Inc. devices

Submission Details

510(k) Number K033881 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 2003
Decision Date March 02, 2004
Days to Decision 78 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 125d · This submission: 78d
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 45
Devices cleared under the same product code (DXT) and FDA review panel - the closest regulatory comparables to K033881.
DiamondTOUCH Inflation Device and Fluid Dispensing Syringe
K160107 · Merit Medical Systems, Inc. · Jul 2016
MEDLINE ANGIOGRAPHIC CONTROL SYRINGE
K093830 · Medline Industries, Inc. · Mar 2011
MONARCH COMPAK INFLATION SYRINGE AND UNIVERSAL FLUID DISPENSING SYRINGE
K083523 · Merit Medical Systems, Inc. · Feb 2009
MONARCH INFLATION SYRINGE
K011811 · Merit Medical Systems, Inc. · Aug 2001
MONARCH (IN 2125)/INTELLISYSTEM (IN 1125)
K973230 · Merit Medical Systems, Inc. · Nov 1997
BD ANGIOGRAPHIC SYRINGE W/A ROTATING TIP
K910873 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1991