Cleared Traditional

K923693 - KLORMAN (FDA 510(k) Clearance)

Class I General Hospital device.

K923693 · Matrix Medica, Inc. · General Hospital
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Jan 1996
Decision
1279d
Days
Class 1
Risk

K923693 is an FDA 510(k) clearance for the KLORMAN. Classified as Disinfectant, Medical Devices (product code LRJ), Class I - General Controls.

Submitted by Matrix Medica, Inc. (Orchard Park, US). The FDA issued a Cleared decision on January 23, 1996 after a review of 1279 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 Matrix Medica, Inc. devices

Submission Details

510(k) Number K923693 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 1992
Decision Date January 23, 1996
Days to Decision 1279 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
1151d slower than avg
Panel avg: 128d · This submission: 1279d
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.