Cleared Traditional

K112686 - NEXT GEN EMG ENDOTRACHEAL TUBE

K112686 is an FDA 510(k) clearance for NEXT GEN EMG ENDOTRACHEAL TUBE, manufactured by Medtronic Xomed, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code ETN cleared through the Traditional 510(k) pathway after a 286-day FDA review.

K112686 · Medtronic Xomed, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2012
Decision
286d
Days
Class 2
Risk

K112686 is an FDA 510(k) clearance for the NEXT GEN EMG ENDOTRACHEAL TUBE. Classified as Stimulator, Nerve (product code ETN), Class II - Special Controls.

Submitted by Medtronic Xomed, Inc. (Jacksonville, US). The FDA issued a Cleared decision on June 27, 2012 after a review of 286 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 Medtronic Xomed, Inc. devices

FDA 510(k) Submission Details - K112686

510(k) Number K112686 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 2011
Decision Date June 27, 2012
Days to Decision 286 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
197d slower than avg
Panel avg: 89d · This submission: 286d
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 41
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