Cleared Traditional

K833246 - TYMPANOSTOMY TUBES-VARIOUS

K833246 is the FDA 510(k) clearance for TYMPANOSTOMY TUBES-VARIOUS by Abco Dealers, Inc.. It is a Class 2 Ear, Nose, Throat device (product code ETD) cleared through the Traditional 510(k) pathway after a 484-day FDA review.

K833246 · Abco Dealers, Inc. · Ear, Nose, Throat device
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Jan 1985
Decision
484d
Days
Class 2
Risk

K833246 is an FDA 510(k) clearance for the TYMPANOSTOMY TUBES-VARIOUS. Classified as Tube, Tympanostomy (product code ETD), Class II - Special Controls.

Submitted by Abco Dealers, Inc. (Walker, US). The FDA issued a Cleared decision on January 4, 1985 after a review of 484 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Ear, Nose, Throat submissions.

View all Abco Dealers, Inc. devices

Submission Details

510(k) Number K833246 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 1983
Decision Date January 04, 1985
Days to Decision 484 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
395d slower than avg
Panel avg: 89d · This submission: 484d
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.

Regulatory Peers - ETD Tube, Tympanostomy

All 62
Devices cleared under the same product code (ETD) and FDA review panel - the closest regulatory comparables to K833246.
VENTILATION TUBES WITH HYDROGEL COATING
K870129 · Richards Medical Co., Inc. · Feb 1987
GOODE T-TUBE WHITE SILICONE TYMPANOSTOMY TUBE
K852387 · Xomed, Inc. · Jan 1986
GODDE T-TUBE BLUE SILICONE TYMPANOSTOMY TUBE
K853641 · Xomed, Inc. · Jan 1986
UNIFLOW VENT TUBE
K842637 · Richards Medical Co., Inc. · Oct 1984
DONALDSON VENT TUBE
K823910 · Treace Medical, Inc. · Nov 1983
CONCEPT T-TUBE
K832361 · Concept, Inc. · Oct 1983