Cleared Traditional

K062015 - CHRONOS VISION EYE TRACKING DEVICE (C-ETD)

K062015 is an FDA 510(k) clearance for CHRONOS VISION EYE TRACKING DEVICE (C-ETD), manufactured by Chronos Vision. The device is a Class 2 Neurology device with product code GWN cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K062015 · Chronos Vision · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2006
Decision
106d
Days
Class 2
Risk

K062015 is an FDA 510(k) clearance for the CHRONOS VISION EYE TRACKING DEVICE (C-ETD). Classified as Nystagmograph (product code GWN), Class II - Special Controls.

Submitted by Chronos Vision (North Reading, US). The FDA issued a Cleared decision on October 31, 2006 after a review of 106 days - within the typical 510(k) review window.

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 - K062015

510(k) Number K062015 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 2006
Decision Date October 31, 2006
Days to Decision 106 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
43d faster than avg
Panel avg: 149d · This submission: 106d
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 55
Devices cleared under the same product code (GWN) and FDA review panel - the closest regulatory comparables to K062015.
VN415M, VN415B, VO425M, V0425B, 2D-VOG GOGGLES, 2D-VOG SYSTEM
K072254 · Interacoustics A/S · Feb 2008
EYETRACKER/IDEAS
K070670 · S.A. Instrumentation Difra · Sep 2007
BALANCEBACK MOBILE INTUITIVE VNG SYSTEM
K070729 · Fall Prevention Technologies, LLC · Mar 2007
FOCUS VNG/ENG TYPE 1068
K061791 · Gn Otometrics A/S · Jul 2006
DDAT OMT
K050098 · Ddat(Uk), Ltd. · May 2005
BALANCEBACK VNG SYSTEM
K042529 · Fall Prevention Technologies, LLC · Oct 2004
K062015 · CHRONOS VISION EYE TRACKING DEVICE (C-ETD)
Download PDF FDA Summary Chronos Vision