Cleared Special

K040298 - ACIST ANTIOGRAPHIC INJECTION SYSTEM CON...

K040298 is an FDA 510(k) clearance for ACIST ANTIOGRAPHIC INJECTION SYSTEM CON..., manufactured by Acist Medical Systems, Inc.. The device is a Class 2 Cardiovascular device with product code DXT cleared through the Special 510(k) pathway after a 35-day FDA review.

K040298 · Acist Medical Systems, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2004
Decision
35d
Days
Class 2
Risk

K040298 is an FDA 510(k) clearance for the ACIST ANTIOGRAPHIC INJECTION SYSTEM CONTRAST MANAGEMENT DISPOSABLE KITS. Classified as Injector And Syringe, Angiographic (product code DXT), Class II - Special Controls.

Submitted by Acist Medical Systems, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on March 15, 2004 after a review of 35 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 Acist Medical Systems, Inc. devices

FDA 510(k) Submission Details - K040298

510(k) Number K040298 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 2004
Decision Date March 15, 2004
Days to Decision 35 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
90d faster than avg
Panel avg: 125d · This submission: 35d
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 111
Devices cleared under the same product code (DXT) and FDA review panel - the closest regulatory comparables to K040298.
CKIS-004A INJECTOR SYNCHRONIZATION OPTION
K061976 · Toshiba America Medical Systems, In.C · Sep 2006
MEDRAD AVANTA FLUID MANAGEMENT INJECTION SYSTEM
K050456 · Medrad, Inc. · Jun 2005
MEDRAD SPECTRIS SOLARIS EP MR INJECTOR SYSTEM
K042784 · Medrad, Inc. · Dec 2004
MEDRAD STELLANT CT INJECTOR SYSTEM WITH IMAGING SYSTEM INTERFACE MODULE
K033881 · Medrad, Inc. · Mar 2004
MEDRAD SPECTRIS SOLARIS MR INJECTOR SYSTEM
K033247 · Medrad, Inc. · Nov 2003
MEDRAD MANUAL SYRINGE LOADER
K031483 · Medrad, Inc. · Aug 2003