Cleared Traditional

K870432 - A1-A2 AMBULATORY EEG CASSETTE RECORDER

K870432 is the FDA 510(k) clearance for A1-A2 AMBULATORY EEG CASSETTE RECORDER by Grass-Telefactor Product Group. It is a Class 2 Neurology device (product code GWQ) cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K870432 · Grass-Telefactor Product Group · Neurology device
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May 1987
Decision
94d
Days
Class 2
Risk

K870432 is an FDA 510(k) clearance for the A1-A2 AMBULATORY EEG CASSETTE RECORDER. Classified as Full-montage Standard Electroencephalograph (product code GWQ), Class II - Special Controls.

Submitted by Grass-Telefactor Product Group (W. Conshohocken, US). The FDA issued a Cleared decision on May 8, 1987 after a review of 94 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 Grass-Telefactor Product Group devices

Submission Details

510(k) Number K870432 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 1987
Decision Date May 08, 1987
Days to Decision 94 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 148d · This submission: 94d
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 89
Devices cleared under the same product code (GWQ) and FDA review panel - the closest regulatory comparables to K870432.
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
NEUROFAX 7310 SERIES (EEG)
K854663 · Nihon Kohden America, Inc. · Aug 1986
MODEL 9000 RECORDING & ELECTROPHYSIOLOGICAL SYSTEM
K860456 · Oxford Medilog, Inc. · Aug 1986
DEL MAR AVIONICS 5509A PHYSIOSCANNER EEG SCANNER
K854268 · Del Mar Avionics · Mar 1986