Cleared Traditional

K152505 - C2 NerveMonitor System

K152505 is an FDA 510(k) clearance for C2 NerveMonitor System, 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 152-day FDA review.

K152505 · Inomed Medizintechnik GmbH · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2016
Decision
152d
Days
Class 2
Risk

K152505 is an FDA 510(k) clearance for the C2 NerveMonitor System. Classified as Stimulator, Nerve (product code ETN), Class II - Special Controls.

Submitted by Inomed Medizintechnik GmbH (Emmendingen Baden- Wuerttemberg, DE). The FDA issued a Cleared decision on February 1, 2016 after a review of 152 days - an extended review cycle.

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 - K152505

510(k) Number K152505 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 2015
Decision Date February 01, 2016
Days to Decision 152 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
63d slower than avg
Panel avg: 89d · This submission: 152d
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
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