Cleared Traditional

K841653 - DEL MAR AVIONICS 5509 NEURO-SCANNER

K841653 is the FDA 510(k) clearance for DEL MAR AVIONICS 5509 NEURO-SCANNER by Del Mar Avionics. It is a Class 2 Neurology device (product code GWQ) cleared through the Traditional 510(k) pathway after a 224-day FDA review.

K841653 · Del Mar Avionics · Neurology device
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Dec 1984
Decision
224d
Days
Class 2
Risk

K841653 is an FDA 510(k) clearance for the DEL MAR AVIONICS 5509 NEURO-SCANNER. Classified as Full-montage Standard Electroencephalograph (product code GWQ), Class II - Special Controls.

Submitted by Del Mar Avionics (Mchenry, US). The FDA issued a Cleared decision on December 3, 1984 after a review of 224 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 K841653 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 1984
Decision Date December 03, 1984
Days to Decision 224 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
76d slower than avg
Panel avg: 148d · This submission: 224d
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 K841653.
MODEL 9000 RECORDING & ELECTROPHYSIOLOGICAL SYSTEM
K860456 · Oxford Medilog, Inc. · Aug 1986
DEL MAR AVIONICS 5509A PHYSIOSCANNER EEG SCANNER
K854268 · Del Mar Avionics · Mar 1986
BUSHEL OFF-HEAD PREAMPLIFIER
K850418 · Oxford Medilog, Inc. · Jun 1985
EEG-4300 W/OPTINAL ACCESS. EEG 4314 &
K842714 · Nihon Kohden America, Inc. · Sep 1984
EEG 42/2P ELECTRO ENCEPHALOGRAPH
K831324 · Nihon Kohden America, Inc. · May 1983
MEDILOG 9000 SYSTEM
K830295 · Oxford Medilog, Inc. · Mar 1983