Cleared Traditional

K890113 - THE CDI(R) SYSTEM 400 (FDA 510(k) Clearance)

Class I Toxicology device.

K890113 · Cardiovascular Devices, Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1989
Decision
132d
Days
Class 1
Risk

K890113 is an FDA 510(k) clearance for the THE CDI(R) SYSTEM 400. Classified as Ion-exchange Chromatography (product code DJY), Class I - General Controls.

Submitted by Cardiovascular Devices, Inc. (Irvine, US). The FDA issued a Cleared decision on May 23, 1989 after a review of 132 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.2230 - the FDA toxicology device 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 Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Cardiovascular Devices, Inc. devices

Submission Details

510(k) Number K890113 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 1989
Decision Date May 23, 1989
Days to Decision 132 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d slower than avg
Panel avg: 87d · This submission: 132d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DJY Ion-exchange Chromatography
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2230
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.