Cleared Traditional

K152915 - EYE-SYNC

K152915 is an FDA 510(k) clearance for EYE-SYNC, manufactured by Syncthink, Inc.. The device is a Class 2 Neurology device with product code GWN cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K152915 · Syncthink, Inc. · Neurology device
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Jan 2016
Decision
119d
Days
Class 2
Risk

K152915 is an FDA 510(k) clearance for the EYE-SYNC. Classified as Nystagmograph (product code GWN), Class II - Special Controls.

Submitted by Syncthink, Inc. (Boston, US). The FDA issued a Cleared decision on January 29, 2016 after a review of 119 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.

View all Syncthink, Inc. devices

FDA 510(k) Submission Details - K152915

510(k) Number K152915 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 2015
Decision Date January 29, 2016
Days to Decision 119 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
29d faster than avg
Panel avg: 148d · This submission: 119d
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 18
Devices cleared under the same product code (GWN) and FDA review panel - the closest regulatory comparables to K152915.
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