Cleared Traditional

FAMILY EAR SCOPE MODEL 29001S (K923304) - FDA 510(k) Clearance

Class I Ear, Nose, Throat device.

K923304 · Ear Care of So. Ca., Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1992
Decision
107d
Days
Class 1
Risk

K923304 is an FDA 510(k) clearance for the FAMILY EAR SCOPE MODEL 29001S. Classified as Otoscope (product code ERA), Class I - General Controls.

Submitted by Ear Care of So. Ca., Inc. (Annapolis, US). The FDA issued a Cleared decision on October 21, 1992 after a review of 107 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 Ear Care of So. Ca., Inc. devices

Submission Details

510(k) Number K923304 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 1992
Decision Date October 21, 1992
Days to Decision 107 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
18d slower than avg
Panel avg: 89d · This submission: 107d
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.