Cleared Traditional

K172271 - Trackit T4 EEG Amplifier

K172271 is the FDA 510(k) clearance for Trackit T4 EEG Amplifier by Lifelines , Ltd.. It is a Class 2 Neurology device (product code GWQ) cleared through the Traditional 510(k) pathway after a 280-day FDA review.

K172271 · Lifelines , Ltd. · Neurology device
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May 2018
Decision
280d
Days
Class 2
Risk

K172271 is an FDA 510(k) clearance for the Trackit T4 EEG Amplifier. Classified as Full-montage Standard Electroencephalograph (product code GWQ), Class II - Special Controls.

Submitted by Lifelines , Ltd. (Over Wallop, GB). The FDA issued a Cleared decision on May 4, 2018 after a review of 280 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1400 - 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 K172271 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 2017
Decision Date May 04, 2018
Days to Decision 280 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
132d slower than avg
Panel avg: 148d · This submission: 280d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GWQ Full-montage Standard Electroencephalograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1400
Definition Acquire, Display, Store, And Archive Electroencephalographic Signals From The Brain Using A Full Montage Array (i.e., 16 Or More Electrodes) And User-specified Locations
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 Consultant

Smith Associates
Yolanda Smith

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - GWQ Full-montage Standard Electroencephalograph

All 93
Devices cleared under the same product code (GWQ) and FDA review panel - the closest regulatory comparables to K172271.
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WR19 System
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Natus Quantum
K180181 · Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) · Feb 2018
NeuroEEG
K173460 · Memory MD, Inc. · Feb 2018