Cleared Traditional

K862903 - MIDDLE EAR VIEWER AND FLUID COLLECTOR

K862903 is an FDA 510(k) clearance for MIDDLE EAR VIEWER AND FLUID COLLECTOR, manufactured by Steven K. Juhn. The device is a Class 1 Ear, Nose, Throat device with product code JZF cleared through the Traditional 510(k) pathway after a 116-day FDA review.

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

FDA 510(k) Submission Details - K862903

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.

JZF Device Classification - Class 1, General Controls

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.