Cleared Traditional

OCIDE HOSPITAL CLEANER-DISINFECTANT (K945227) - FDA 510(k) Clearance

Class I General Hospital device.

K945227 · Clariant Corporation · General Hospital
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Mar 1995
Decision
148d
Days
Class 1
Risk

K945227 is an FDA 510(k) clearance for the OCIDE HOSPITAL CLEANER-DISINFECTANT. Classified as Disinfectant, Medical Devices (product code LRJ), Class I - General Controls.

Submitted by Clariant Corporation (Wilmington, US). The FDA issued a Cleared decision on March 23, 1995 after a review of 148 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 Clariant Corporation devices

Submission Details

510(k) Number K945227 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 1994
Decision Date March 23, 1995
Days to Decision 148 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
19d slower than avg
Panel avg: 129d · This submission: 148d
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.