Cleared Traditional

K070670 - EYETRACKER/IDEAS

K070670 is an FDA 510(k) clearance for EYETRACKER/IDEAS, manufactured by S.A. Instrumentation Difra. The device is a Class 2 Neurology device with product code GWN cleared through the Traditional 510(k) pathway after a 190-day FDA review.

K070670 · S.A. Instrumentation Difra · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2007
Decision
190d
Days
Class 2
Risk

K070670 is an FDA 510(k) clearance for the EYETRACKER/IDEAS. Classified as Nystagmograph (product code GWN), Class II - Special Controls.

Submitted by S.A. Instrumentation Difra (Cheyenne, US). The FDA issued a Cleared decision on September 18, 2007 after a review of 190 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 S.A. Instrumentation Difra devices

FDA 510(k) Submission Details - K070670

510(k) Number K070670 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 2007
Decision Date September 18, 2007
Days to Decision 190 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
42d slower than avg
Panel avg: 148d · This submission: 190d
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 32
Devices cleared under the same product code (GWN) and FDA review panel - the closest regulatory comparables to K070670.
VisualEyes
K152112 · Interacoustics A/S · Dec 2015
EYESEECAM VHIT
K131681 · Interacoustics A/S · Sep 2013
VN415M, VN415B, VO425M, V0425B, 2D-VOG GOGGLES, 2D-VOG SYSTEM
K072254 · Interacoustics A/S · Feb 2008
EXPRESSEYE
K992473 · Optomotor Laboratories · Aug 1999
EYE TRAK TM, COMPUTERIZED ELECTRONYSTAGMOGRAPH (ENG), MODEL ETV-XXXX
K991642 · Bertec Corp. · Aug 1999
ICS MEDICAL CHARTR ENG/VNG DIAGNOSTIC SYSTEM
K991497 · Ics Medical Corp. · Jul 1999