Cleared Traditional

SKYTRON EXAM LIGHT (K933564) - FDA 510(k) Clearance

Class I General Hospital device.

K933564 · Skytron, Div. the Kmw Group, Inc. · General Hospital
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Feb 1994
Decision
203d
Days
Class 1
Risk

K933564 is an FDA 510(k) clearance for the SKYTRON EXAM LIGHT. Classified as Device, Medical Examination, Ac Powered (product code KZF), Class I - General Controls.

Submitted by Skytron, Div. the Kmw Group, Inc. (Grand Rapids, US). The FDA issued a Cleared decision on February 10, 1994 after a review of 203 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 Skytron, Div. the Kmw Group, Inc. devices

Submission Details

510(k) Number K933564 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 1993
Decision Date February 10, 1994
Days to Decision 203 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
74d slower than avg
Panel avg: 129d · This submission: 203d
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.