Cleared Traditional

RENALIN COLD STERILANT (K941439) - FDA 510(k) Clearance

Class I General Hospital device.

K941439 · Minntech Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1995
Decision
459d
Days
Class 1
Risk

K941439 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 June 26, 1995 after a review of 459 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Minntech Corp. devices

Submission Details

510(k) Number K941439 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 1994
Decision Date June 26, 1995
Days to Decision 459 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
330d slower than avg
Panel avg: 129d · This submission: 459d
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.