Cleared Traditional

K882564 - RENALIN COLD STERILANT

K882564 is an FDA 510(k) clearance for RENALIN COLD STERILANT, manufactured by Minntech Corp.. The device is a Class 1 General Hospital device with product code LRJ cleared through the Traditional 510(k) pathway after a 202-day FDA review.

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

FDA 510(k) Submission Details - K882564

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
73d slower than avg
Panel avg: 129d · This submission: 202d
Pathway characteristics
Predicate-based equivalence.

LRJ Device Classification - Class 1, General Controls

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.