Cleared Traditional

K152727 - ISEN-Goggles (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K152727 · Isen Tech & Trading Company, Ltd. · Neurology device
Download Printable Device Report (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.

View all Isen Tech & Trading Company, Ltd. devices

Submission Details

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
Regulatory Context
Review time vs. panel average
69d slower than avg
Panel avg: 148d · This submission: 217d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 58
Devices cleared under the same product code (GWN) and FDA review panel - the closest regulatory comparables to K152727.
NeuroEars-Anna™
K243709 · Neuroears, Inc. · Aug 2025
ICS Dizcovery (1091)
K242198 · Natus Medical Denmark Aps · Feb 2025
Synapsys VHIT
K242726 · Inventis S.R.L. · Jan 2025
NeuroSwift Pro
K223047 · Neurobit Technologies Co., Ltd. · Jun 2023
Insight Infrared Video Goggles
K203082 · Vestibular First · Nov 2020
VisualEyes
K200534 · Interacoustics A/S · Aug 2020