Cleared Traditional

K925640 - XOMED-TREACE EMG ENDOTRACHEAL TUBEEN

K925640 is an FDA 510(k) clearance for XOMED-TREACE EMG ENDOTRACHEAL TUBEEN, manufactured by Xomed-Treace, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code ETN cleared through the Traditional 510(k) pathway after a 281-day FDA review.

K925640 · Xomed-Treace, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1993
Decision
281d
Days
Class 2
Risk

K925640 is an FDA 510(k) clearance for the XOMED-TREACE EMG ENDOTRACHEAL TUBEEN. Classified as Stimulator, Nerve (product code ETN), Class II - Special Controls.

Submitted by Xomed-Treace, Inc. (Jacksonville, US). The FDA issued a Cleared decision on August 17, 1993 after a review of 281 days - an extended review cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.1820 - 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 Xomed-Treace, Inc. devices

FDA 510(k) Submission Details - K925640

510(k) Number K925640 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 1992
Decision Date August 17, 1993
Days to Decision 281 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
191d slower than avg
Panel avg: 90d · This submission: 281d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ETN Device Classification - Class 2, Special Controls

Product Code ETN Stimulator, Nerve
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.1820
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 - ETN Stimulator, Nerve

All 77
Devices cleared under the same product code (ETN) and FDA review panel - the closest regulatory comparables to K925640.
NEUROSIGN 800, 8 CHANNEL MOTOR NERVE MONITOR
K964869 · The Magstim Company , Ltd. · May 1997
STIMULATING SURGICAL INSTRUMENTS
K934733 · Smith & Nephew Richards, Inc. · Jul 1994
R AND D BATTERIES, INC. PART NOS. 5038 & 5347
K933491 · R & D Batteries, Inc. · Nov 1993
NERVE LOCATOR/STIMULATOR
K905045 · Aaron Medical Industries · Mar 1991
RESUBMITTED JUNIPER T.M. JOINT DISTRACTION FORCEPS
K881757 · Downs Surgical , Ltd. · Jul 1988
MONTGOMERY NERVE STIMULATOR
K880720 · Boston Medical Products, Inc. · May 1988