Cleared Traditional

K152727 - ISEN-Goggles

K152727 is an FDA 510(k) clearance for ISEN-Goggles, manufactured by Isen 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 217-day FDA review.

K152727 · Isen Tech & Trading Company, Ltd. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2016
Decision
217d
Days
Class 2
Risk

K152727 is an FDA 510(k) clearance for the ISEN-Goggles. Classified as Nystagmograph (product code GWN), Class II - Special Controls.

Submitted by Isen Tech & Trading Company, Ltd. (Beijing, CN). The FDA issued a Cleared decision on April 26, 2016 after a review of 217 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.

FDA 510(k) Submission Details - K152727

510(k) Number K152727 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 2015
Decision Date April 26, 2016
Days to Decision 217 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
68d slower than avg
Panel avg: 149d · This submission: 217d
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

Bovard Consulting, LLC
LINDA J BOVARD

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 K152727.
ISEN-Goggles with Data Viewer
K163270 · Isent Tech & Trading Company, Ltd. · Sep 2017
VisualEyes
K163149 · Interacoustics A/S · Apr 2017
Synapsys Ulmer Video Nystagmograph
K163558 · Synapsys SA · Mar 2017
EYE-SYNC
K152915 · Syncthink, Inc. · Jan 2016
VisualEyes
K152112 · Interacoustics A/S · Dec 2015
ICS Impulse
K151504 · Gn Otometrics · Nov 2015
K152727 · ISEN-Goggles
Download PDF FDA Summary Isen Tech & Trading C…