Cleared Traditional

K122040 - INVOTEC LARYNGEAL ELECTRODE

K122040 is an FDA 510(k) clearance for INVOTEC LARYNGEAL ELECTRODE, manufactured by Invotec International, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code ETN cleared through the Traditional 510(k) pathway after a 476-day FDA review.

K122040 · Invotec International, Inc. · Ear, Nose, Throat device
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Oct 2013
Decision
476d
Days
Class 2
Risk

K122040 is an FDA 510(k) clearance for the INVOTEC LARYNGEAL ELECTRODE. Classified as Stimulator, Nerve (product code ETN), Class II - Special Controls.

Submitted by Invotec International, Inc. (Jacksonville, US). The FDA issued a Cleared decision on October 31, 2013 after a review of 476 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Ear, Nose, Throat submissions.

View all Invotec International, Inc. devices

FDA 510(k) Submission Details - K122040

510(k) Number K122040 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 2012
Decision Date October 31, 2013
Days to Decision 476 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
386d slower than avg
Panel avg: 90d · This submission: 476d
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 73
Devices cleared under the same product code (ETN) and FDA review panel - the closest regulatory comparables to K122040.
Checkpoint, Checkpoint Head & Neck
K150005 · Ndi Medical, LLC · Feb 2015
STIM PROBE
K133348 · Spes Medica Srl · Nov 2014
ES2 NEUROMONITORING ACCESSORY INSTRUMENTS
K140400 · Stryker Corporation · Jul 2014
NONDISPOSABLE STIMULATING INSTRUMENTS
K121931 · Neurovision Medical Products, Inc. · Oct 2012
LARYNGEAL ELECTRODE
K121257 · Technomed Europe · Aug 2012
NEXT GEN EMG ENDOTRACHEAL TUBE
K112686 · Medtronic Xomed, Inc. · Jun 2012