Cleared Traditional

K943721 - OTOVIEW TELESCOPIC OTOSCOPES (FDA 510(k) Clearance)

Class I Ear, Nose, Throat device.

K943721 · Smith & Nephew, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1994
Decision
109d
Days
Class 1
Risk

K943721 is an FDA 510(k) clearance for the OTOVIEW TELESCOPIC OTOSCOPES. Classified as Otoscope (product code ERA), Class I - General Controls.

Submitted by Smith & Nephew, Inc. (Bartlett, US). The FDA issued a Cleared decision on November 18, 1994 after a review of 109 days - within the typical 510(k) review window.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4770 - 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, Inc. devices

Submission Details

510(k) Number K943721 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 1994
Decision Date November 18, 1994
Days to Decision 109 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
20d slower than avg
Panel avg: 89d · This submission: 109d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code ERA Otoscope
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.4770
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.