Cleared Traditional

K854268 - DEL MAR AVIONICS 5509A PHYSIOSCANNER EE...

K854268 is the FDA 510(k) clearance for DEL MAR AVIONICS 5509A PHYSIOSCANNER EE... by Del Mar Avionics. It is a Class 2 Neurology device (product code GWQ) cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K854268 · Del Mar Avionics · Neurology device
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Mar 1986
Decision
155d
Days
Class 2
Risk

K854268 is an FDA 510(k) clearance for the DEL MAR AVIONICS 5509A PHYSIOSCANNER EEG SCANNER. Classified as Full-montage Standard Electroencephalograph (product code GWQ), Class II - Special Controls.

Submitted by Del Mar Avionics (Irvine, US). The FDA issued a Cleared decision on March 27, 1986 after a review of 155 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 Del Mar Avionics devices

Submission Details

510(k) Number K854268 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 1985
Decision Date March 27, 1986
Days to Decision 155 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
7d slower than avg
Panel avg: 148d · This submission: 155d
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 Peers - GWQ Full-montage Standard Electroencephalograph

All 88
Devices cleared under the same product code (GWQ) and FDA review panel - the closest regulatory comparables to K854268.
MODEL 5000 AMBULATORY MONITORING SYSTEM
K871500 · Oxford Medilog, Inc. · Jul 1987
NEUROFAX 7310 SERIES (EEG)
K854663 · Nihon Kohden America, Inc. · Aug 1986
MODEL 9000 RECORDING & ELECTROPHYSIOLOGICAL SYSTEM
K860456 · Oxford Medilog, Inc. · Aug 1986
BUSHEL OFF-HEAD PREAMPLIFIER
K850418 · Oxford Medilog, Inc. · Jun 1985
DEL MAR AVIONICS 5509 NEURO-SCANNER
K841653 · Del Mar Avionics · Dec 1984
EEG-4300 W/OPTINAL ACCESS. EEG 4314 &
K842714 · Nihon Kohden America, Inc. · Sep 1984