Cleared Traditional

K820510 - TYMPANOSTOMY TUBES (VARIOUS MODELS

K820510 is an FDA 510(k) clearance for TYMPANOSTOMY TUBES (VARIOUS MODELS, manufactured by Abco Dist.. The device is a Class 2 Ear, Nose, Throat device with product code ETD cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K820510 · Abco Dist. · Ear, Nose, Throat device
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Mar 1982
Decision
24d
Days
Class 2
Risk

K820510 is an FDA 510(k) clearance for the TYMPANOSTOMY TUBES (VARIOUS MODELS. Classified as Tube, Tympanostomy (product code ETD), Class II - Special Controls.

Submitted by Abco Dist. (Mchenry, US). The FDA issued a Cleared decision on March 19, 1982 after a review of 24 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 Abco Dist. devices

FDA 510(k) Submission Details - K820510

510(k) Number K820510 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 1982
Decision Date March 19, 1982
Days to Decision 24 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
65d faster than avg
Panel avg: 89d · This submission: 24d
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 K820510.
ARMSTRONG V VENT TUBE
K822375 · Treace Medical, Inc. · Sep 1982
TYTAN REUTER BOBBIN VENT TUBE
K822376 · Treace Medical, Inc. · Sep 1982
TYTAN GROMMET VENT TUBE, .040
K822366 · Treace Medical, Inc. · Sep 1982
REUTER BOBBIN VENTILA. TUBE-TITANIUM
K820362 · Richard'S Medical Equip., Inc. · Mar 1982
EXMOOR AURAL GROMMET AG/TI
K812459 · Exmoor Plastics , Ltd. · Sep 1981
VARIOUS AURAL GROMMETS
K812460 · Exmoor Plastics , Ltd. · Sep 1981