Cleared Traditional

K151600 - R-40 EEG Amplifier

K151600 is the FDA 510(k) clearance for R-40 EEG Amplifier by Lifelines , Ltd.. It is a Class 2 Neurology device (product code GWL) cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K151600 · Lifelines , Ltd. · Neurology device
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Oct 2015
Decision
133d
Days
Class 2
Risk

K151600 is an FDA 510(k) clearance for the R-40 EEG Amplifier. Classified as Amplifier, Physiological Signal (product code GWL), Class II - Special Controls.

Submitted by Lifelines , Ltd. (Over Wallop, GB). The FDA issued a Cleared decision on October 23, 2015 after a review of 133 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1835 - 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 Lifelines , Ltd. devices

Submission Details

510(k) Number K151600 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 2015
Decision Date October 23, 2015
Days to Decision 133 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
15d faster than avg
Panel avg: 148d · This submission: 133d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GWL Amplifier, Physiological Signal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1835
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 - GWL Amplifier, Physiological Signal

All 18
Devices cleared under the same product code (GWL) and FDA review panel - the closest regulatory comparables to K151600.
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