Cleared Traditional

K963727 - HOFFMAN H/A COATED LONG-TERM VENTILATION TUBE WITH LINER

K963727 is an FDA 510(k) clearance for HOFFMAN H/A COATED LONG-TERM VENTILATIO..., manufactured by Medtronic Xomed. The device is a Class 2 Ear, Nose, Throat device with product code ETD cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K963727 · Medtronic Xomed · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1997
Decision
148d
Days
Class 2
Risk

K963727 is an FDA 510(k) clearance for the HOFFMAN H/A COATED LONG-TERM VENTILATION TUBE WITH LINER. Classified as Tube, Tympanostomy (product code ETD), Class II - Special Controls.

Submitted by Medtronic Xomed (Jacksonville, US). The FDA issued a Cleared decision on February 11, 1997 after a review of 148 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 Medtronic Xomed devices

FDA 510(k) Submission Details - K963727

510(k) Number K963727 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 1996
Decision Date February 11, 1997
Days to Decision 148 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
58d slower than avg
Panel avg: 90d · This submission: 148d
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 84
Devices cleared under the same product code (ETD) and FDA review panel - the closest regulatory comparables to K963727.
TYMPANOSTOMY VENTILATION TUBE
K971454 · Ikonos Corp. · May 1997
TM MICRO-CATHETERS
K971124 · Xomed, Inc. · May 1997
ROUND WINDOW CATH
K965115 · Neuro-Biometrix, Inc. · Mar 1997
ACTIVENT ANTIMICROBIAL VENTILATION TUBES
K961873 · Xomed, Inc. · Jul 1996
TYMPANOSTOMY VENTILATION TUBE
K961945 · Advanced Microbotics Corp. · Jun 1996
TYMPANOSTOMY VENTILATION TUBE
K960742 · Advanced Microbotics Corp. · Apr 1996