Cleared Traditional

K172735 - WR19 System

K172735 is an FDA 510(k) clearance for WR19 System, manufactured by Zeto, Inc.. The device is a Class 2 Neurology device with product code GWQ cleared through the Traditional 510(k) pathway after a 218-day FDA review.

K172735 · Zeto, Inc. · Neurology device
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Optimized for regulatory review, auditing and printing
Apr 2018
Decision
218d
Days
Class 2
Risk

K172735 is an FDA 510(k) clearance for the WR19 System. Classified as Full-montage Standard Electroencephalograph (product code GWQ), Class II - Special Controls.

Submitted by Zeto, Inc. (Santa Clara, US). The FDA issued a Cleared decision on April 17, 2018 after a review of 218 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 Zeto, Inc. devices

FDA 510(k) Submission Details - K172735

510(k) Number K172735 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 2017
Decision Date April 17, 2018
Days to Decision 218 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
70d slower than avg
Panel avg: 148d · This submission: 218d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GWQ Device Classification - Class 2, Special Controls

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

Biologics Consulting Group
Donna-Bea Tillman

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 142
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