Cleared Abbreviated

K020892 - ACIST GENTOO CONTRAST INJECTION SYSTEM

K020892 is an FDA 510(k) clearance for ACIST GENTOO CONTRAST INJECTION SYSTEM, manufactured by Acist Medical Systems. The device is a Class 2 Cardiovascular device with product code DXT cleared through the Abbreviated 510(k) pathway after a 314-day FDA review.

K020892 · Acist Medical Systems · Cardiovascular device
Download Printable Device Report (PDF)
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Jan 2003
Decision
314d
Days
Class 2
Risk

K020892 is an FDA 510(k) clearance for the ACIST GENTOO CONTRAST INJECTION SYSTEM. Classified as Injector And Syringe, Angiographic (product code DXT), Class II - Special Controls.

Submitted by Acist Medical Systems (Eden Prairie, US). The FDA issued a Cleared decision on January 27, 2003 after a review of 314 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1650 - the FDA cardiovascular device oversight framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Acist Medical Systems devices

FDA 510(k) Submission Details - K020892

510(k) Number K020892 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 2002
Decision Date January 27, 2003
Days to Decision 314 days
Submission Type Abbreviated
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
189d slower than avg
Panel avg: 125d · This submission: 314d
Pathway characteristics
Standards-based clearance path.

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 121
Devices cleared under the same product code (DXT) and FDA review panel - the closest regulatory comparables to K020892.
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
MEDRAD STELLANT CT INJECTOR SYSTEM
K023183 · Medrad, Inc. · Jan 2003
MEDRAD QWIK-FIT SYRINGE
K013815 · Medrad, Inc. · Dec 2001
MODIFICATION TO: MEDRAD SPECTRIS SOLARIS MR INJECTOR SYSTEM
K012950 · Medrad, Inc. · Oct 2001