Cleared Traditional

K853641 - GODDE T-TUBE BLUE SILICONE TYMPANOSTOMY TUBE

K853641 is an FDA 510(k) clearance for GODDE T-TUBE BLUE SILICONE TYMPANOSTOMY..., manufactured by Xomed, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code ETD cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K853641 · Xomed, Inc. · Ear, Nose, Throat device
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Jan 1986
Decision
125d
Days
Class 2
Risk

K853641 is an FDA 510(k) clearance for the GODDE T-TUBE BLUE SILICONE TYMPANOSTOMY TUBE. Classified as Tube, Tympanostomy (product code ETD), Class II - Special Controls.

Submitted by Xomed, Inc. (Jacksonville, US). The FDA issued a Cleared decision on January 6, 1986 after a review of 125 days - within the typical 510(k) review window.

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: 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 Xomed, Inc. devices

FDA 510(k) Submission Details - K853641

510(k) Number K853641 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 1985
Decision Date January 06, 1986
Days to Decision 125 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
35d slower than avg
Panel avg: 90d · This submission: 125d
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 89
Devices cleared under the same product code (ETD) and FDA review panel - the closest regulatory comparables to K853641.
'EXMOOR' T-TUBE
K871035 · Exmoor Plastics , Ltd. · Mar 1987
VENTILATION TUBES WITH HYDROGEL COATING
K870129 · Richards Medical Co., Inc. · Feb 1987
GOODE T-TUBE WHITE SILICONE TYMPANOSTOMY TUBE
K852387 · Xomed, Inc. · Jan 1986
TYMPANOSTOMY TUBES-VARIOUS
K833246 · Abco Dealers, Inc. · Jan 1985
UNIFLOW VENT TUBE
K842637 · Richards Medical Co., Inc. · Oct 1984
DONALDSON VENT TUBE
K823910 · Treace Medical, Inc. · Nov 1983