Cleared Traditional

K130201 - NYSTAGRAM VIDEO NYSTAGMOGRAPHY SYSTEM

K130201 is an FDA 510(k) clearance for NYSTAGRAM VIDEO NYSTAGMOGRAPHY SYSTEM, manufactured by Ototronix, LLC. The device is a Class 2 Neurology device with product code GWN cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K130201 · Ototronix, LLC · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2013
Decision
88d
Days
Class 2
Risk

K130201 is an FDA 510(k) clearance for the NYSTAGRAM VIDEO NYSTAGMOGRAPHY SYSTEM. Classified as Nystagmograph (product code GWN), Class II - Special Controls.

Submitted by Ototronix, LLC (St. Paul, US). The FDA issued a Cleared decision on April 26, 2013 after a review of 88 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ototronix, LLC devices

FDA 510(k) Submission Details - K130201

510(k) Number K130201 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 2013
Decision Date April 26, 2013
Days to Decision 88 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
60d faster than avg
Panel avg: 148d · This submission: 88d
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 K130201.
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