Cleared Traditional

ACTILLUME (K894044) - FDA 510(k) Clearance

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

K894044 · Ambulatory Monitoring, Inc. · Neurology device
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Dec 1989
Decision
198d
Days
Class 2
Risk

K894044 is an FDA 510(k) clearance for the ACTILLUME. Classified as Full-montage Standard Electroencephalograph (product code GWQ), Class II - Special Controls.

Submitted by Ambulatory Monitoring, Inc. (Ardsley, US). The FDA issued a Cleared decision on December 22, 1989 after a review of 198 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 Ambulatory Monitoring, Inc. devices

Submission Details

510(k) Number K894044 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 1989
Decision Date December 22, 1989
Days to Decision 198 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d slower than avg
Panel avg: 148d · This submission: 198d
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 43
Devices cleared under the same product code (GWQ) and FDA review panel - the closest regulatory comparables to K894044.
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K884537 · Nihon Kohden America, Inc. · Dec 1988
MODEL EEG 4400 WITH OPTIONAL ACCESSORIES
K874796 · Nihon Kohden America, Inc. · Jan 1988
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K854663 · Nihon Kohden America, Inc. · Aug 1986