Cleared Traditional

K960477 - VENTILATION TUBES

K960477 is the FDA 510(k) clearance for VENTILATION TUBES by Smith & Nephew, Inc.. It is a Class 2 Ear, Nose, Throat device (product code ETD) cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K960477 · Smith & Nephew, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1996
Decision
25d
Days
Class 2
Risk

K960477 is an FDA 510(k) clearance for the VENTILATION TUBES. Classified as Tube, Tympanostomy (product code ETD), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (Washington, US). The FDA issued a Cleared decision on February 26, 1996 after a review of 25 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, Inc. devices

Submission Details

510(k) Number K960477 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 1996
Decision Date February 26, 1996
Days to Decision 25 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
64d faster than avg
Panel avg: 89d · This submission: 25d
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 K960477.
SHAH PERMAVENT
K974007 · Exmoor Plastics , Ltd. · Dec 1997
TM MICRO-CATHETERS
K971124 · Xomed, Inc. · May 1997
ACTIVENT ANTIMICROBIAL VENTILATION TUBES
K961873 · Xomed, Inc. · Jul 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