Cleared Traditional

K140400 - ES2 NEUROMONITORING ACCESSORY INSTRUMENTS

K140400 is an FDA 510(k) clearance for ES2 NEUROMONITORING ACCESSORY INSTRUMENTS, manufactured by Stryker Corporation. The device is a Class 2 Ear, Nose, Throat device with product code ETN cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K140400 · Stryker Corporation · Ear, Nose, Throat device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2014
Decision
133d
Days
Class 2
Risk

K140400 is an FDA 510(k) clearance for the ES2 NEUROMONITORING ACCESSORY INSTRUMENTS. Classified as Stimulator, Nerve (product code ETN), Class II - Special Controls.

Submitted by Stryker Corporation (Allendale, US). The FDA issued a Cleared decision on July 1, 2014 after a review of 133 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.

FDA 510(k) Submission Details - K140400

510(k) Number K140400 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 2014
Decision Date July 01, 2014
Days to Decision 133 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
43d slower than avg
Panel avg: 90d · This submission: 133d
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 92
Devices cleared under the same product code (ETN) and FDA review panel - the closest regulatory comparables to K140400.
C2 NerveMonitor System
K152505 · Inomed Medizintechnik GmbH · Feb 2016
Checkpoint, Checkpoint Head & Neck
K150005 · Ndi Medical, LLC · Feb 2015
STIM PROBE
K133348 · Spes Medica Srl · Nov 2014
INVOTEC LARYNGEAL ELECTRODE
K122040 · Invotec International, Inc. · Oct 2013
NONDISPOSABLE STIMULATING INSTRUMENTS
K121931 · Neurovision Medical Products, Inc. · Oct 2012
LARYNGEAL ELECTRODE
K121257 · Technomed Europe · Aug 2012
K140400 · ES2 NEUROMONITORING ACCESSORY INSTRUMENTS
Download PDF FDA Summary Stryker Corporation