Cleared Traditional

K971454 - TYMPANOSTOMY VENTILATION TUBE

K971454 is an FDA 510(k) clearance for TYMPANOSTOMY VENTILATION TUBE, manufactured by Ikonos Corp.. The device is a Class 2 Ear, Nose, Throat device with product code ETD cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K971454 · Ikonos Corp. · Ear, Nose, Throat device
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May 1997
Decision
38d
Days
Class 2
Risk

K971454 is an FDA 510(k) clearance for the TYMPANOSTOMY VENTILATION TUBE. Classified as Tube, Tympanostomy (product code ETD), Class II - Special Controls.

Submitted by Ikonos Corp. (Portland, US). The FDA issued a Cleared decision on May 29, 1997 after a review of 38 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 Ikonos Corp. devices

FDA 510(k) Submission Details - K971454

510(k) Number K971454 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 1997
Decision Date May 29, 1997
Days to Decision 38 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 89d · This submission: 38d
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 K971454.
EXMOOR MYRINGOTOMY KIT
K980828 · Exmoor Plastics , Ltd. · Oct 1998
PFLEIDERER'S INTRATYMPANIC CATHETER
K974008 · Exmoor Plastics , Ltd. · May 1998
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
VENTILATION TUBES
K960477 · Smith & Nephew, Inc. · Feb 1996