Cleared Traditional

K954795 - AT2 & DOYLE STYLE (C-FLEX) VENT TUBES

K954795 is an FDA 510(k) clearance for AT2 & DOYLE STYLE (C-FLEX) VENT TUBES, manufactured by Trebay Medical Corp.. The device is a Class 2 Ear, Nose, Throat device with product code ETD cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K954795 · Trebay Medical Corp. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1995
Decision
28d
Days
Class 2
Risk

K954795 is an FDA 510(k) clearance for the AT2 & DOYLE STYLE (C-FLEX) VENT TUBES. Classified as Tube, Tympanostomy (product code ETD), Class II - Special Controls.

Submitted by Trebay Medical Corp. (Clearwater, US). The FDA issued a Cleared decision on November 15, 1995 after a review of 28 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 Trebay Medical Corp. devices

FDA 510(k) Submission Details - K954795

510(k) Number K954795 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 1995
Decision Date November 15, 1995
Days to Decision 28 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
61d faster than avg
Panel avg: 89d · This submission: 28d
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 K954795.
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
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