Cleared Traditional

K934432 - OTOVIEW ENDOSCOPY SYSTEM (FDA 510(k) Clearance)

Class I Ear, Nose, Throat device.

K934432 · Smith & Nephew Richards, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1994
Decision
224d
Days
Class 1
Risk

K934432 is an FDA 510(k) clearance for the OTOVIEW ENDOSCOPY SYSTEM. Classified as Set, Audiometer Calibration (product code EWA), Class I - General Controls.

Submitted by Smith & Nephew Richards, Inc. (Bartlett, US). The FDA issued a Cleared decision on April 25, 1994 after a review of 224 days - an extended review cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.1080 - 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 Smith & Nephew Richards, Inc. devices

Submission Details

510(k) Number K934432 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 1993
Decision Date April 25, 1994
Days to Decision 224 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
135d slower than avg
Panel avg: 89d · This submission: 224d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EWA Set, Audiometer Calibration
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.1080
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.