Cleared Traditional

K984058 - ACIST INJECTOR SYSTEM, MODEL CL100 H (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K984058 · Acist Medical Systems · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Feb 1999
Decision
90d
Days
Class 2
Risk

K984058 is an FDA 510(k) clearance for the ACIST INJECTOR SYSTEM, MODEL CL100 H. Classified as Injector, Contrast Medium, Automatic (product code IZQ), Class II - Special Controls.

Submitted by Acist Medical Systems (Eden Prairie, US). The FDA issued a Cleared decision on February 11, 1999 after a review of 90 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Acist Medical Systems devices

Submission Details

510(k) Number K984058 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1998
Decision Date February 11, 1999
Days to Decision 90 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 125d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IZQ Injector, Contrast Medium, Automatic
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 - IZQ Injector, Contrast Medium, Automatic

All 21
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