Cleared Traditional

K091874 - INOMED ADHESIVE LARYNGEAL ELECTRODES, MODELS 530655, 530656 (FDA 510(k) Clearance)

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

K091874 · Inomed Medizintechnik GmbH · Ear, Nose, Throat device
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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

Submission Details

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.

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
Devices cleared under the same product code (ETN) and FDA review panel - the closest regulatory comparables to K091874.
Evala Nerve Stimulator (EPNR002)
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