Cleared Traditional

ILLUMINATOR II (K922277) - FDA 510(k) Clearance

Class I General Hospital device.

K922277 · Medical Illumination, Inc. · General Hospital
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Feb 1993
Decision
266d
Days
Class 1
Risk

K922277 is an FDA 510(k) clearance for the ILLUMINATOR II. Classified as Device, Medical Examination, Ac Powered (product code KZF), Class I - General Controls.

Submitted by Medical Illumination, Inc. (Arleta, US). The FDA issued a Cleared decision on February 5, 1993 after a review of 266 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6320 - 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 Medical Illumination, Inc. devices

Submission Details

510(k) Number K922277 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 1992
Decision Date February 05, 1993
Days to Decision 266 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
137d slower than avg
Panel avg: 129d · This submission: 266d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KZF Device, Medical Examination, Ac Powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6320
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.