Cleared Traditional

K123821 - AIO HD OTOSCOPE (FDA 510(k) Clearance)

Class I Ear, Nose, Throat device.

K123821 · Blue Focus · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2013
Decision
156d
Days
Class 1
Risk

K123821 is an FDA 510(k) clearance for the AIO HD OTOSCOPE. Classified as Otoscope (product code ERA), Class I - General Controls.

Submitted by Blue Focus (Lawrenceville, US). The FDA issued a Cleared decision on May 17, 2013 after a review of 156 days - an extended review cycle.

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 Blue Focus devices

Submission Details

510(k) Number K123821 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 2012
Decision Date May 17, 2013
Days to Decision 156 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
67d slower than avg
Panel avg: 89d · This submission: 156d
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.