Cleared Traditional

EYETRACKER/IDEAS (K070670) - FDA 510(k) Clearance

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

K070670 · S.A. Instrumentation Difra · Neurology device
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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

Submission Details

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.

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.

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All 58
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