Cleared Traditional

K923353 - VENTILATION TUBES W/ HYDROGEL COATING

K923353 is an FDA 510(k) clearance for VENTILATION TUBES W/ HYDROGEL COATING, manufactured by Microbio-Medics, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code ETD cleared through the Traditional 510(k) pathway after a 314-day FDA review.

K923353 · Microbio-Medics, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1993
Decision
314d
Days
Class 2
Risk

K923353 is an FDA 510(k) clearance for the VENTILATION TUBES W/ HYDROGEL COATING. Classified as Tube, Tympanostomy (product code ETD), Class II - Special Controls.

Submitted by Microbio-Medics, Inc. (Memphis, US). The FDA issued a Cleared decision on May 18, 1993 after a review of 314 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Microbio-Medics, Inc. devices

FDA 510(k) Submission Details - K923353

510(k) Number K923353 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 1992
Decision Date May 18, 1993
Days to Decision 314 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
225d slower than avg
Panel avg: 89d · This submission: 314d
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 K923353.
ACTIVENT ANTIMICROBIAL VENTILATION TUBES
K961873 · Xomed, Inc. · Jul 1996
VENTILATION TUBES
K960477 · Smith & Nephew, Inc. · Feb 1996
SILICONE TYMPANOSTOMY TUBES
K932166 · Smith & Nephew Richards, Inc. · Jul 1993
BEL-AIR VENTILATION TUBE
K926462 · Exmoor Plastics , Ltd. · May 1993
TITANIUM VENTILATION TUBES
K921923 · Exmoor Plastics , Ltd. · Feb 1993
DONALDSON/SHEPARDS DR/COLLAR/SHAH VENT-MINI TUBES
K911580 · Exmoor Plastics , Ltd. · Sep 1991