Cleared Traditional

RENALIN COLD STERILANT (K882564) - FDA 510(k) Clearance

Class I General Hospital device.

K882564 · Minntech Corp. · General Hospital
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Jan 1989
Decision
202d
Days
Class 1
Risk

K882564 is an FDA 510(k) clearance for the RENALIN COLD STERILANT. Classified as Disinfectant, Medical Devices (product code LRJ), Class I - General Controls.

Submitted by Minntech Corp. (Minneapolis, US). The FDA issued a Cleared decision on January 9, 1989 after a review of 202 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6890 - the FDA general hospital 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Minntech Corp. devices

Submission Details

510(k) Number K882564 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 1988
Decision Date January 09, 1989
Days to Decision 202 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d slower than avg
Panel avg: 129d · This submission: 202d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LRJ Disinfectant, Medical Devices
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6890
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.