Cleared Traditional

K890113 - THE CDI(R) SYSTEM 400

K890113 is an FDA 510(k) clearance for THE CDI SYSTEM 400, manufactured by Cardiovascular Devices, Inc.. The device is a Class 1 Toxicology device with product code DJY cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K890113 · Cardiovascular Devices, Inc. · Toxicology device
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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

FDA 510(k) Submission Details - K890113

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.

DJY Device Classification - Class 1, General Controls

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.

Regulatory Peers - DJY Ion-exchange Chromatography

All 7
Devices cleared under the same product code (DJY) and FDA review panel - the closest regulatory comparables to K890113.
LIQUID CHROMATOGRAPHY COLUMNS 5-7070/71/72/73
K883615 · Supelco, Inc. · Dec 1988
SOLID PHASE EXTRACTION TUBES
K881361 · Supelco, Inc. · Aug 1988
DUPONT PREP TYPE SI EXTRACITON CARTRIDGE
K850963 · E.I. Dupont DE Nemours & Co., Inc. · Mar 1985
TRISACRYL GF 05 & TRISACRYL GF 2000
K840985 · Lkb Instruments, Inc. · Apr 1984
DUPONT PREP OD EXTRACTION CARTRIDE
K830692 · E.I. Dupont DE Nemours & Co., Inc. · Apr 1983
DUPONT PREP TYPE AS EXTRACTION CARTRIDE
K830693 · E.I. Dupont DE Nemours & Co., Inc. · Apr 1983