Cleared Traditional

K121257 - LARYNGEAL ELECTRODE

K121257 is the FDA 510(k) clearance for LARYNGEAL ELECTRODE by Technomed Europe. It is a Class 2 Ear, Nose, Throat device (product code ETN) cleared through the Traditional 510(k) pathway after a 124-day FDA review.

K121257 · Technomed Europe · Ear, Nose, Throat device
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Aug 2012
Decision
124d
Days
Class 2
Risk

K121257 is an FDA 510(k) clearance for the LARYNGEAL ELECTRODE. Classified as Stimulator, Nerve (product code ETN), Class II - Special Controls.

Submitted by Technomed Europe (Maastricht-Airport, NL). The FDA issued a Cleared decision on August 28, 2012 after a review of 124 days - within the typical 510(k) review window.

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 Technomed Europe devices

Submission Details

510(k) Number K121257 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 2012
Decision Date August 28, 2012
Days to Decision 124 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
35d slower than avg
Panel avg: 89d · This submission: 124d
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 39
Devices cleared under the same product code (ETN) and FDA review panel - the closest regulatory comparables to K121257.
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K112718 · Nuvasive, Inc. · Mar 2012