Cleared Traditional

I22 INITIALES (K862621) - FDA 510(k) Clearance

Class I Ear, Nose, Throat device.

K862621 · Oticon Corp. · Ear, Nose, Throat device
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Aug 1986
Decision
22d
Days
Class 1
Risk

K862621 is an FDA 510(k) clearance for the I22 INITIALES. Classified as Otoscope (product code ERA), Class I - General Controls.

Submitted by Oticon Corp. (Somerset, US). The FDA issued a Cleared decision on August 1, 1986 after a review of 22 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Oticon Corp. devices

Submission Details

510(k) Number K862621 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 1986
Decision Date August 01, 1986
Days to Decision 22 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 89d · This submission: 22d
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.