Cleared Traditional

K122550 - ICS IMPULSE

K122550 is an FDA 510(k) clearance for ICS IMPULSE, manufactured by Gn Otometrics. The device is a Class 2 Neurology device with product code GWN cleared through the Traditional 510(k) pathway after a 164-day FDA review.

K122550 · Gn Otometrics · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2013
Decision
164d
Days
Class 2
Risk

K122550 is an FDA 510(k) clearance for the ICS IMPULSE. Classified as Nystagmograph (product code GWN), Class II - Special Controls.

Submitted by Gn Otometrics (Naples, US). The FDA issued a Cleared decision on February 1, 2013 after a review of 164 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1460 - the FDA neurology 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 Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Gn Otometrics devices

FDA 510(k) Submission Details - K122550

510(k) Number K122550 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 2012
Decision Date February 01, 2013
Days to Decision 164 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d slower than avg
Panel avg: 148d · This submission: 164d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GWN Device Classification - Class 2, Special Controls

Product Code GWN Nystagmograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1460
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 Neurology devices follow this clearance model.

Regulatory Peers - GWN Nystagmograph

All 17
Devices cleared under the same product code (GWN) and FDA review panel - the closest regulatory comparables to K122550.
RightEye Vision System
K181771 · Righteye, LLC · Sep 2018
DizzyDoctor System 1.0.0
K182214 · Dizzydoctor Systems, LLC · Sep 2018
I-Portal Neuro Otologic Test Center
K181025 · Neuro Kinetics, Inc. · Jul 2018
VARIOUS ELECTRODES
K941928 · Bio-Logic Systems Corp. · Feb 1995
JANUS ATAC ENG ANALYSIS SYSTEM
K904385 · Life-Tech Intl., Inc. · Jun 1992
ELECTROCARDIOGRAPH CONTINUOUS MONITOR
K860457 · Oxford Medilog, Inc. · Apr 1986