Cleared Traditional

K163270 - ISEN-Goggles with Data Viewer (FDA 510(k) Clearance)

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

K163270 · Isent Tech & Trading Company, Ltd. · Neurology device
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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.

View all Isent Tech & Trading Company, Ltd. devices

Submission Details

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
Regulatory Context
Review time vs. panel average
160d slower than avg
Panel avg: 148d · This submission: 308d
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
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