Cleared Traditional

K050162 - CONTACT EMG ROTATABLE ENDOTRACHEAL TUBE

K050162 is an FDA 510(k) clearance for CONTACT EMG ROTATABLE 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 37-day FDA review.

K050162 · Medtronic Xomed, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2005
Decision
37d
Days
Class 2
Risk

K050162 is an FDA 510(k) clearance for the CONTACT EMG ROTATABLE 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 March 3, 2005 after a review of 37 days - a notably fast clearance 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: 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 Medtronic Xomed, Inc. devices

FDA 510(k) Submission Details - K050162

510(k) Number K050162 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 2005
Decision Date March 03, 2005
Days to Decision 37 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
52d faster than avg
Panel avg: 89d · This submission: 37d
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
Devices cleared under the same product code (ETN) and FDA review panel - the closest regulatory comparables to K050162.
STIMULATING BUR GUARD
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NUVASIVE NEUROVISION JJB SYSTEM
K051718 · Nuvasive, Inc. · Sep 2005
NUVASIVE NEUROVISION JJB SYSTEM
K040543 · Nuvasive, Inc. · Apr 2004
NUVASIVE NEUROVISION JJB SYSTEM
K032083 · Nuvasive, Inc. · Oct 2003
STIMULUS/DISSECTION INSTRUMENTS, BALL-TIP PROBES
K031003 · Medtronic Xomed, Inc. · Apr 2003