Cleared Traditional

K091874 - INOMED ADHESIVE LARYNGEAL ELECTRODES

K091874 is an FDA 510(k) clearance for INOMED ADHESIVE LARYNGEAL ELECTRODES, manufactured by Inomed Medizintechnik GmbH. The device is a Class 2 Ear, Nose, Throat device with product code ETN cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K091874 · Inomed Medizintechnik GmbH · Ear, Nose, Throat device
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Optimized for regulatory review, auditing and printing
Nov 2009
Decision
148d
Days
Class 2
Risk

K091874 is an FDA 510(k) clearance for the INOMED ADHESIVE LARYNGEAL ELECTRODES, MODELS 530655, 530656. Classified as Stimulator, Nerve (product code ETN), Class II - Special Controls.

Submitted by Inomed Medizintechnik GmbH (Crofton, US). The FDA issued a Cleared decision on November 18, 2009 after a review of 148 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 Inomed Medizintechnik GmbH devices

FDA 510(k) Submission Details - K091874

510(k) Number K091874 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 2009
Decision Date November 18, 2009
Days to Decision 148 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
59d slower than avg
Panel avg: 89d · This submission: 148d
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 43
Devices cleared under the same product code (ETN) and FDA review panel - the closest regulatory comparables to K091874.
STIMULATION/DISSECTION INSTRUMENTS
K112709 · Nu Vasive, Incorporated · Feb 2012
SEASPINE MONOPOLAR PROBE SYSYEM
K111671 · Seaspine, Inc. · Dec 2011
DISPOSABLE STIMULATING ELECTRODE
K111597 · Nuvasive, Inc. · Oct 2011
STIMULATING BUR GUARD
K063305 · Medtronic Xomed, Inc. · Nov 2006
XLTEK STIMULATOR PROBES, MODELS 105233, 105234, 105235, 105236, 105237 AND 105238
K062549 · Excel Tech. , Ltd. · Oct 2006
NUVASIVE NEUROVISION JJB SYSTEM
K051718 · Nuvasive, Inc. · Sep 2005