Cleared Traditional

AE-800PA EEG MODULE (K884537) - FDA 510(k) Clearance

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K884537 · Nihon Kohden America, Inc. · Neurology device
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Dec 1988
Decision
62d
Days
Class 2
Risk

K884537 is an FDA 510(k) clearance for the AE-800PA EEG MODULE. Classified as Full-montage Standard Electroencephalograph (product code GWQ), Class II - Special Controls.

Submitted by Nihon Kohden America, Inc. (Irvine, US). The FDA issued a Cleared decision on December 29, 1988 after a review of 62 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Nihon Kohden America, Inc. devices

Submission Details

510(k) Number K884537 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1988
Decision Date December 29, 1988
Days to Decision 62 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
86d faster than avg
Panel avg: 148d · This submission: 62d
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 42
Devices cleared under the same product code (GWQ) and FDA review panel - the closest regulatory comparables to K884537.
NIHON KOHDEN ELECTROENCEPHALOGRAPH
K944678 · Nihon Kohden America, Inc. · May 1995
NEUROFAX EEG 5532
K915096 · Nihon Kohden America, Inc. · Mar 1992
EEG-5400 SERIES
K902550 · Nihon Kohden America, Inc. · Mar 1991
MODEL EEG 4400 WITH OPTIONAL ACCESSORIES
K874796 · Nihon Kohden America, Inc. · Jan 1988
NEUROFAX 7310 SERIES (EEG)
K854663 · Nihon Kohden America, Inc. · Aug 1986
EEG-4300 W/OPTINAL ACCESS. EEG 4314 &
K842714 · Nihon Kohden America, Inc. · Sep 1984