Cleared Traditional

MEDDEV MULTARRAY (TM) MEDICAL EXAMINATION LIGHT (K931197) - FDA 510(k) Clearance

Class I General Hospital device.

K931197 · Meddev International Corp. · General Hospital
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Sep 1993
Decision
198d
Days
Class 1
Risk

K931197 is an FDA 510(k) clearance for the MEDDEV MULTARRAY (TM) MEDICAL EXAMINATION LIGHT. Classified as Device, Medical Examination, Ac Powered (product code KZF), Class I - General Controls.

Submitted by Meddev International Corp. (Los Altos, US). The FDA issued a Cleared decision on September 23, 1993 after a review of 198 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 Meddev International Corp. devices

Submission Details

510(k) Number K931197 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 1993
Decision Date September 23, 1993
Days to Decision 198 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
69d slower than avg
Panel avg: 129d · This submission: 198d
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.