Cleared Traditional

TYMPANOSTOMY VENTILATION TUBE (K960742) - FDA 510(k) Clearance

Class II Ear, Nose, Throat device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K960742 · Advanced Microbotics Corp. · Ear, Nose, Throat device
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Apr 1996
Decision
40d
Days
Class 2
Risk

K960742 is an FDA 510(k) clearance for the TYMPANOSTOMY VENTILATION TUBE. Classified as Tube, Tympanostomy (product code ETD), Class II - Special Controls.

Submitted by Advanced Microbotics Corp. (Portland, US). The FDA issued a Cleared decision on April 3, 1996 after a review of 40 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3880 - 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 Advanced Microbotics Corp. devices

Submission Details

510(k) Number K960742 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 1996
Decision Date April 03, 1996
Days to Decision 40 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 89d · This submission: 40d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ETD Tube, Tympanostomy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.3880
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ear, Nose, Throat devices follow this clearance model.