Cleared Traditional

K932771 - BATTERY POWERED, DISPOSABLE ENDOSCOPE LIGHT SOURCE (FDA 510(k) Clearance)

Class I Ear, Nose, Throat device.

K932771 · Xomed-Treace, Inc. · Ear, Nose, Throat device
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Optimized for regulatory review, auditing and printing
Aug 1994
Decision
442d
Days
Class 1
Risk

K932771 is an FDA 510(k) clearance for the BATTERY POWERED, DISPOSABLE ENDOSCOPE LIGHT SOURCE. Classified as Source, Carrier, Fiberoptic Light (product code EQH), Class I - General Controls.

Submitted by Xomed-Treace, Inc. (Jacksonville, US). The FDA issued a Cleared decision on August 24, 1994 after a review of 442 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Ear, Nose, Throat submissions.

View all Xomed-Treace, Inc. devices

Submission Details

510(k) Number K932771 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 1993
Decision Date August 24, 1994
Days to Decision 442 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
353d slower than avg
Panel avg: 89d · This submission: 442d
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.