Cleared Traditional

K802638 - OTOLOGICAL VENTILATION TUBES

K802638 is the FDA 510(k) clearance for OTOLOGICAL VENTILATION TUBES by Santa Barbara Medco, Inc.. It is a Class 2 Ear, Nose, Throat device (product code ETD) cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K802638 · Santa Barbara Medco, Inc. · Ear, Nose, Throat device
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Nov 1980
Decision
21d
Days
Class 2
Risk

K802638 is an FDA 510(k) clearance for the OTOLOGICAL VENTILATION TUBES. Classified as Tube, Tympanostomy (product code ETD), Class II - Special Controls.

Submitted by Santa Barbara Medco, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 12, 1980 after a review of 21 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 Santa Barbara Medco, Inc. devices

Submission Details

510(k) Number K802638 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 1980
Decision Date November 12, 1980
Days to Decision 21 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
68d faster than avg
Panel avg: 89d · This submission: 21d
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 65
Devices cleared under the same product code (ETD) and FDA review panel - the closest regulatory comparables to K802638.
EXMOOR AURAL GROMMET AG/T3
K810704 · Exmoor Plastics , Ltd. · Apr 1981
EXMOOR AURAL GROMMET AG/T4
K810705 · Exmoor Plastics , Ltd. · Apr 1981
EXMOOR AURAL GROMMET AG/T5
K810706 · Exmoor Plastics , Ltd. · Apr 1981
GOODE T-TUBE, BIOLITE COATED SILICONE/TU
K800727 · Xomed, Inc. · Apr 1980
PAPARELL TYPE 2, BIOLITE COATED SILI-
K800728 · Xomed, Inc. · Apr 1980
POPE UMBRELLA TUBE
K791680 · Xomed, Inc. · Nov 1979