Cleared Traditional

PHENO-CEN GERMICIDAL DETERGENT (K951162) - FDA 510(k) Clearance

Class I General Hospital device.

K951162 · Central Solutions, Inc. · General Hospital
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Optimized for regulatory review, auditing and printing
Jul 1995
Decision
119d
Days
Class 1
Risk

K951162 is an FDA 510(k) clearance for the PHENO-CEN GERMICIDAL DETERGENT. Classified as Disinfectant, Medical Devices (product code LRJ), Class I - General Controls.

Submitted by Central Solutions, Inc. (Kansas City, US). The FDA issued a Cleared decision on July 11, 1995 after a review of 119 days - within the typical 510(k) review window.

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 Central Solutions, Inc. devices

Submission Details

510(k) Number K951162 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 1995
Decision Date July 11, 1995
Days to Decision 119 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
10d faster than avg
Panel avg: 129d · This submission: 119d
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.