Cleared Traditional

K830228 - OTOLOGICAL VENTILATION TUBES-VARIOUS

K830228 is the FDA 510(k) clearance for OTOLOGICAL VENTILATION TUBES-VARIOUS by Micromedics, Inc.. It is a Class 2 Ear, Nose, Throat device (product code ETD) cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K830228 · Micromedics, Inc. · Ear, Nose, Throat device
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Mar 1983
Decision
42d
Days
Class 2
Risk

K830228 is an FDA 510(k) clearance for the OTOLOGICAL VENTILATION TUBES-VARIOUS. Classified as Tube, Tympanostomy (product code ETD), Class II - Special Controls.

Submitted by Micromedics, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 7, 1983 after a review of 42 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 Micromedics, Inc. devices

Submission Details

510(k) Number K830228 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 1983
Decision Date March 07, 1983
Days to Decision 42 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
47d faster than avg
Panel avg: 89d · This submission: 42d
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 63
Devices cleared under the same product code (ETD) and FDA review panel - the closest regulatory comparables to K830228.
DONALDSON-TYPE VENT TUBE
K832362 · Concept, Inc. · Oct 1983
SOILEAU TYTAN BOBBIN VENT TUBE
K830584 · Treace Medical, Inc. · Jun 1983
T-TUBE VENT TUBE
K823909 · Treace Medical, Inc. · Mar 1983
COLLAR BUTTON VENT TUBE
K823907 · Treace Medical, Inc. · Jan 1983
GROMMET VENT TUBE
K823908 · Treace Medical, Inc. · Jan 1983
COLLAR BUTTON VENT TUBE
K830085 · Treace Medical, Inc. · Jan 1983