Cleared Traditional

K061058 - NEOZOLINE VENTILATION TUBES

K061058 is an FDA 510(k) clearance for NEOZOLINE VENTILATION TUBES, manufactured by Adept Medical, Ltd.. The device is a Class 2 Ear, Nose, Throat device with product code ETD cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K061058 · Adept Medical, Ltd. · Ear, Nose, Throat device
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Jul 2006
Decision
86d
Days
Class 2
Risk

K061058 is an FDA 510(k) clearance for the NEOZOLINE VENTILATION TUBES. Classified as Tube, Tympanostomy (product code ETD), Class II - Special Controls.

Submitted by Adept Medical, Ltd. (Auckland, NZ). The FDA issued a Cleared decision on July 12, 2006 after a review of 86 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 Adept Medical, Ltd. devices

FDA 510(k) Submission Details - K061058

510(k) Number K061058 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 2006
Decision Date July 12, 2006
Days to Decision 86 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
3d faster than avg
Panel avg: 89d · This submission: 86d
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 K061058.
Ventilation (Tympanostomy) Tubes
K151067 · Medtronic Xomed, Inc. · Jul 2015
ACCLARENT TYMPANOSTOMY TUBE AND TYMPANOSTOMY TUBE DELIVERY SYSTEM
K103595 · Acclarent, Inc. · Apr 2011
TYMPANOSTOMY TUBE
K082188 · Acclarent, Inc. · Sep 2008
PC COATED FLUOROPLASTIC VENT TUBES
K000801 · Gyrus Ent LLC · Jun 2000
SILVERSTEIN MICROWICK
K991670 · Micromedics, Inc. · Aug 1999
FLUOROPLASTIC VENTILATION TUBES
K992222 · Gyrus Ent LLC · Aug 1999