Cleared Traditional

F.T.I. MEDICAL LIGHT GUIDE (K904378) - FDA 510(k) Clearance

Class I Ear, Nose, Throat device.

K904378 · Fiberoptics Technology, Inc. · Ear, Nose, Throat device
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Jan 1991
Decision
114d
Days
Class 1
Risk

K904378 is an FDA 510(k) clearance for the F.T.I. MEDICAL LIGHT GUIDE. Classified as Source, Carrier, Fiberoptic Light (product code EQH), Class I - General Controls.

Submitted by Fiberoptics Technology, Inc. (Pomfret, US). The FDA issued a Cleared decision on January 16, 1991 after a review of 114 days - within the typical 510(k) review window.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4350 - the FDA ear, nose and throat 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 Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Fiberoptics Technology, Inc. devices

Submission Details

510(k) Number K904378 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 1990
Decision Date January 16, 1991
Days to Decision 114 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d slower than avg
Panel avg: 89d · This submission: 114d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EQH Source, Carrier, Fiberoptic Light
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.4350
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.