Cleared Traditional

K932166 - SILICONE TYMPANOSTOMY TUBES

K932166 is the FDA 510(k) clearance for SILICONE TYMPANOSTOMY TUBES by Smith & Nephew Richards, Inc.. It is a Class 2 Ear, Nose, Throat device (product code ETD) cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K932166 · Smith & Nephew Richards, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1993
Decision
83d
Days
Class 2
Risk

K932166 is an FDA 510(k) clearance for the SILICONE TYMPANOSTOMY TUBES. Classified as Tube, Tympanostomy (product code ETD), Class II - Special Controls.

Submitted by Smith & Nephew Richards, Inc. (Bartlett, US). The FDA issued a Cleared decision on July 26, 1993 after a review of 83 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 Smith & Nephew Richards, Inc. devices

Submission Details

510(k) Number K932166 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 1993
Decision Date July 26, 1993
Days to Decision 83 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
6d faster than avg
Panel avg: 89d · This submission: 83d
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 68
Devices cleared under the same product code (ETD) and FDA review panel - the closest regulatory comparables to K932166.
TM MICRO-CATHETERS
K971124 · Xomed, Inc. · May 1997
ACTIVENT ANTIMICROBIAL VENTILATION TUBES
K961873 · Xomed, Inc. · Jul 1996
VENTILATION TUBES
K960477 · Smith & Nephew, Inc. · Feb 1996
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