Cleared Traditional

K122040 - INVOTEC LARYNGEAL ELECTRODE (FDA 510(k) Clearance)

Class II Ear, Nose, Throat device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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
Regulatory Context
Review time vs. panel average
387d slower than avg
Panel avg: 89d · This submission: 476d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 96
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