Cleared Traditional

K863193 - SENTINEL 4 EEG ANALYZER

K863193 is an FDA 510(k) clearance for SENTINEL 4 EEG ANALYZER, manufactured by Axon Systems, Inc.. The device is a Class 2 Neurology device with product code GWQ cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K863193 · Axon Systems, Inc. · Neurology device
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Dec 1986
Decision
105d
Days
Class 2
Risk

K863193 is an FDA 510(k) clearance for the SENTINEL 4 EEG ANALYZER. Classified as Full-montage Standard Electroencephalograph (product code GWQ), Class II - Special Controls.

Submitted by Axon Systems, Inc. (Deer Park, US). The FDA issued a Cleared decision on December 2, 1986 after a review of 105 days - within the typical 510(k) review window.

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 Axon Systems, Inc. devices

FDA 510(k) Submission Details - K863193

510(k) Number K863193 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 1986
Decision Date December 02, 1986
Days to Decision 105 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 148d · This submission: 105d
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 Peers - GWQ Full-montage Standard Electroencephalograph

All 94
Devices cleared under the same product code (GWQ) and FDA review panel - the closest regulatory comparables to K863193.
MODEL EEG 4400 WITH OPTIONAL ACCESSORIES
K874796 · Nihon Kohden America, Inc. · Jan 1988
AMBULATORY EEG PLAYBACK
K872183 · Cadwell Laboratories, Inc. · Jul 1987
MODEL 5000 AMBULATORY MONITORING SYSTEM
K871500 · Oxford Medilog, Inc. · Jul 1987
TECA/ECEM T5 PORTABLE ELECTROENCEPHALOGRAPH
K863749 · Teca, Inc. · Oct 1986
NEUROFAX 7310 SERIES (EEG)
K854663 · Nihon Kohden America, Inc. · Aug 1986
MODEL 9000 RECORDING & ELECTROPHYSIOLOGICAL SYSTEM
K860456 · Oxford Medilog, Inc. · Aug 1986