Cleared Special

K010390 - ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL R2000-CMS

K010390 is an FDA 510(k) clearance for ACIST ANGIOGRAPHIC INJECTION SYSTEM, 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 28-day FDA review.

K010390 · Acist Medical Systems, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2001
Decision
28d
Days
Class 2
Risk

K010390 is an FDA 510(k) clearance for the ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL R2000-CMS. 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 9, 2001 after a review of 28 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.

FDA 510(k) Submission Details - K010390

510(k) Number K010390 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 2001
Decision Date March 09, 2001
Days to Decision 28 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
97d faster than avg
Panel avg: 125d · This submission: 28d
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 197
Devices cleared under the same product code (DXT) and FDA review panel - the closest regulatory comparables to K010390.
MODIFICATION TO: MEDRAD SPECTRIS SOLARIS MR INJECTOR SYSTEM
K012950 · Medrad, Inc. · Oct 2001
MONARCH INFLATION SYRINGE
K011811 · Merit Medical Systems, Inc. · Aug 2001
MODIFICATION TO MEDRAD SPECTRIS MR INJECTOR
K011991 · Medrad, Inc. · Aug 2001
FRONT-LOAD POLYPROPYLENE SYRINGE
K001663 · Medrad, Inc. · Nov 2000
ANGIOGRAPHIC CONTRAST MANAGEMENT SYSTEM, MODEL PART A AND PART B
K984231 · Invasatec · May 2000
MODIFICATION TO ACIST CL 100H
K991103 · Acist Medical Systems · May 2000
K010390 · ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL R2000-CMS
Download PDF FDA Summary Acist Medical Systems…