Cleared Traditional

MIDDLE EAR VIEWER AND FLUID COLLECTOR (K862903) - FDA 510(k) Clearance

Class I Ear, Nose, Throat device.

K862903 · Steven K. Juhn · Ear, Nose, Throat device
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Nov 1986
Decision
116d
Days
Class 1
Risk

K862903 is an FDA 510(k) clearance for the MIDDLE EAR VIEWER AND FLUID COLLECTOR. Classified as Tube, Ear Suction (product code JZF), Class I - General Controls.

Submitted by Steven K. Juhn (Minneapolis, US). The FDA issued a Cleared decision on November 24, 1986 after a review of 116 days - within the typical 510(k) review window.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4420 - 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 Steven K. Juhn devices

Submission Details

510(k) Number K862903 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 1986
Decision Date November 24, 1986
Days to Decision 116 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
27d slower than avg
Panel avg: 89d · This submission: 116d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JZF Tube, Ear Suction
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.4420
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.