Cleared Traditional

K062385 - BLUE PTFE (FLUOROPLASTIC) VENTILATION TUBES

K062385 is an FDA 510(k) clearance for BLUE PTFE (FLUOROPLASTIC) VENTILATION TUBES, manufactured by Grace Medical, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code ETD cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K062385 · Grace Medical, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2006
Decision
43d
Days
Class 2
Risk

K062385 is an FDA 510(k) clearance for the BLUE PTFE (FLUOROPLASTIC) VENTILATION TUBES. Classified as Tube, Tympanostomy (product code ETD), Class II - Special Controls.

Submitted by Grace Medical, Inc. (Memphis, US). The FDA issued a Cleared decision on September 27, 2006 after a review of 43 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 Grace Medical, Inc. devices

FDA 510(k) Submission Details - K062385

510(k) Number K062385 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 2006
Decision Date September 27, 2006
Days to Decision 43 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 89d · This submission: 43d
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 K062385.
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