Cleared Traditional

K163270 - ISEN-Goggles with Data Viewer

K163270 is an FDA 510(k) clearance for ISEN-Goggles with Data Viewer, manufactured by Isent Tech & Trading Company, Ltd.. The device is a Class 2 Neurology device with product code GWN cleared through the Traditional 510(k) pathway after a 308-day FDA review.

K163270 · Isent Tech & Trading Company, Ltd. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2017
Decision
308d
Days
Class 2
Risk

K163270 is an FDA 510(k) clearance for the ISEN-Goggles with Data Viewer. Classified as Nystagmograph (product code GWN), Class II - Special Controls.

Submitted by Isent Tech & Trading Company, Ltd. (Beijing, CN). The FDA issued a Cleared decision on September 25, 2017 after a review of 308 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K163270

510(k) Number K163270 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2016
Decision Date September 25, 2017
Days to Decision 308 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
159d slower than avg
Panel avg: 149d · This submission: 308d
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 Consultant

Vision28
TIM RENNER

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - GWN Nystagmograph

All 54
Devices cleared under the same product code (GWN) and FDA review panel - the closest regulatory comparables to K163270.
DizzyDoctor System 1.0.0
K182214 · Dizzydoctor Systems, LLC · Sep 2018
I-Portal Neuro Otologic Test Center
K181025 · Neuro Kinetics, Inc. · Jul 2018
I-Portal Portable Assessment System - Nystagmograph (I-PAS)
K171884 · Neuro Kinetics, Inc. · Nov 2017
VisualEyes
K163149 · Interacoustics A/S · Apr 2017
Synapsys Ulmer Video Nystagmograph
K163558 · Synapsys SA · Mar 2017
ISEN-Goggles
K152727 · Isen Tech & Trading Company, Ltd. · Apr 2016
K163270 · ISEN-Goggles with Data Viewer
Download PDF FDA Summary Isent Tech & Trading …