Cleared Traditional

K061791 - FOCUS VNG/ENG TYPE 1068

K061791 is an FDA 510(k) clearance for FOCUS VNG/ENG TYPE 1068, manufactured by Gn Otometrics A/S. The device is a Class 2 Neurology device with product code GWN cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K061791 · Gn Otometrics A/S · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2006
Decision
15d
Days
Class 2
Risk

K061791 is an FDA 510(k) clearance for the FOCUS VNG/ENG TYPE 1068. Classified as Nystagmograph (product code GWN), Class II - Special Controls.

Submitted by Gn Otometrics A/S (Schaumburg, US). The FDA issued a Cleared decision on July 11, 2006 after a review of 15 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 Gn Otometrics A/S devices

FDA 510(k) Submission Details - K061791

510(k) Number K061791 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 2006
Decision Date July 11, 2006
Days to Decision 15 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
133d faster than avg
Panel avg: 148d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 K061791.
RightEye Vision System
K181771 · Righteye, LLC · Sep 2018
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K182214 · Dizzydoctor Systems, LLC · Sep 2018
I-Portal Neuro Otologic Test Center
K181025 · Neuro Kinetics, Inc. · Jul 2018
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K860457 · Oxford Medilog, Inc. · Apr 1986