Cleared Traditional

K894044 - ACTILLUME

K894044 is an FDA 510(k) clearance for ACTILLUME, manufactured by Ambulatory Monitoring, Inc.. The device is a Class 2 Neurology device with product code GWQ cleared through the Traditional 510(k) pathway after a 198-day FDA review.

K894044 · Ambulatory Monitoring, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K894044

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.

GWQ Device Classification - Class 2, Special Controls

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 97
Devices cleared under the same product code (GWQ) and FDA review panel - the closest regulatory comparables to K894044.
EE1114, 1118, 1121 ELECTRO-ENCEPHALOGRAPH
K903004 · Teca, Inc. · Nov 1990
SPACELABS MODEL 90480 EEG MODULE
K896942 · Spacelabs, Inc. · Mar 1990
P460, DG32 ELECTROENCEPHALOGRAPH
K896666 · Teca, Inc. · Feb 1990
CEEGRAPH
K895125 · Bio-Logic Systems Corp. · Dec 1989
CADWELL FREEDOM EEG DEVICE
K894276 · Cadwell Laboratories, Inc. · Sep 1989
TECA 1A96, 1A97 AND 1A98 ELECTROENCEPHALOGRAPHS
K890881 · Teca, Inc. · Mar 1989