Cleared Special

K023183 - MEDRAD STELLANT CT INJECTOR SYSTEM

K023183 is an FDA 510(k) clearance for MEDRAD STELLANT CT INJECTOR SYSTEM, manufactured by Medrad, Inc.. The device is a Class 2 Cardiovascular device with product code DXT cleared through the Special 510(k) pathway after a 108-day FDA review.

K023183 · Medrad, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2003
Decision
108d
Days
Class 2
Risk

K023183 is an FDA 510(k) clearance for the MEDRAD STELLANT CT INJECTOR SYSTEM. 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 January 10, 2003 after a review of 108 days - within the typical 510(k) review window.

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

FDA 510(k) Submission Details - K023183

510(k) Number K023183 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2002
Decision Date January 10, 2003
Days to Decision 108 days
Submission Type Special
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
17d faster than avg
Panel avg: 125d · This submission: 108d
Pathway characteristics
Modification to existing cleared device.

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 210
Devices cleared under the same product code (DXT) and FDA review panel - the closest regulatory comparables to K023183.
MEDRAD MANUAL SYRINGE LOADER
K031483 · Medrad, Inc. · Aug 2003
OPTIBOLUS
K031339 · Mallinckrodt Inc., Liebel-Flarsheim Business · Jul 2003
ACIST GENTOO CONTRAST INJECTION SYSTEM
K020892 · Acist Medical Systems · Jan 2003
ELPH INJECTION SYSTEM
K022116 · Mallinckrodt Inc., Liebel-Flarsheim Business · Jul 2002
ATRION MEDICAL QL FLUID DISPENSING SYRINGE
K020333 · Atrion Medical Products, Inc. · Apr 2002
MEDRAD QWIK-FIT SYRINGE
K013815 · Medrad, Inc. · Dec 2001
K023183 · MEDRAD STELLANT CT INJECTOR SYSTEM
Download PDF FDA Summary Medrad, Inc.