Cleared Traditional

K110696 - NEURO CHECK DEVICE WITH IO-FLEX WIRE

K110696 is an FDA 510(k) clearance for NEURO CHECK DEVICE WITH IO-FLEX WIRE, manufactured by Baxano, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code ETN cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K110696 · Baxano, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2011
Decision
115d
Days
Class 2
Risk

K110696 is an FDA 510(k) clearance for the NEURO CHECK DEVICE WITH IO-FLEX WIRE. Classified as Stimulator, Nerve (product code ETN), Class II - Special Controls.

Submitted by Baxano, Inc. (San Jose, US). The FDA issued a Cleared decision on July 7, 2011 after a review of 115 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 - K110696

510(k) Number K110696 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 2011
Decision Date July 07, 2011
Days to Decision 115 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
25d slower than avg
Panel avg: 90d · This submission: 115d
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 84
Devices cleared under the same product code (ETN) and FDA review panel - the closest regulatory comparables to K110696.
NEUROVISION INK PRINTED ENDOTRACHEAL TUBE ELECTRODE
K110989 · Neurovision Medical Products, Inc. · Nov 2011
DISPOSABLE STIMULATING ELECTRODE
K111597 · Nuvasive, Inc. · Oct 2011
RHYTHMLINK MONOPOLAR STIMULATING INSTRUMENT
K112435 · Rhythmlink International, LLC · Sep 2011
DRYTOUCH SUCTION STIMULATOR PROBE
K110712 · Neurovision Medical Products, Inc. · Jun 2011
SURGICAL STIMULATORS
K110422 · Technomed Europe · May 2011
PAIRED HYDROGEL ELECTRODE
K110138 · Neurovision Medical Products, Inc. · Apr 2011