Cleared Traditional

K955447 - TYMPANOSTOMY TUBE

K955447 is an FDA 510(k) clearance for TYMPANOSTOMY TUBE, manufactured by Trebay Medical Corp.. The device is a Class 2 Ear, Nose, Throat device with product code ETD cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K955447 · Trebay Medical Corp. · Ear, Nose, Throat device
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Dec 1995
Decision
22d
Days
Class 2
Risk

K955447 is an FDA 510(k) clearance for the TYMPANOSTOMY TUBE. Classified as Tube, Tympanostomy (product code ETD), Class II - Special Controls.

Submitted by Trebay Medical Corp. (Clearwater, US). The FDA issued a Cleared decision on December 21, 1995 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 874.3880 - 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 Trebay Medical Corp. devices

FDA 510(k) Submission Details - K955447

510(k) Number K955447 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 1995
Decision Date December 21, 1995
Days to Decision 22 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
67d faster than avg
Panel avg: 89d · This submission: 22d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ETD Device Classification - Class 2, Special Controls

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.

Regulatory Peers - ETD Tube, Tympanostomy

All 69
Devices cleared under the same product code (ETD) and FDA review panel - the closest regulatory comparables to K955447.
TM MICRO-CATHETERS
K971124 · Xomed, Inc. · May 1997
ACTIVENT ANTIMICROBIAL VENTILATION TUBES
K961873 · Xomed, Inc. · Jul 1996
VENTILATION TUBES
K960477 · Smith & Nephew, Inc. · Feb 1996
SILICONE TYMPANOSTOMY TUBES
K932166 · Smith & Nephew Richards, Inc. · Jul 1993
BEL-AIR VENTILATION TUBE
K926462 · Exmoor Plastics , Ltd. · May 1993
TITANIUM VENTILATION TUBES
K921923 · Exmoor Plastics , Ltd. · Feb 1993