Cleared Traditional

K983533 - ACTIWATCH

K983533 is an FDA 510(k) clearance for ACTIWATCH, manufactured by Mini-Mitter Co., Inc.. The device is a Class 2 Neurology device with product code GWQ cleared through the Traditional 510(k) pathway after a 166-day FDA review.

K983533 · Mini-Mitter Co., Inc. · Neurology device
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Mar 1999
Decision
166d
Days
Class 2
Risk

K983533 is an FDA 510(k) clearance for the ACTIWATCH. Classified as Full-montage Standard Electroencephalograph (product code GWQ), Class II - Special Controls.

Submitted by Mini-Mitter Co., Inc. (Sunriver, US). The FDA issued a Cleared decision on March 23, 1999 after a review of 166 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 Mini-Mitter Co., Inc. devices

FDA 510(k) Submission Details - K983533

510(k) Number K983533 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 08, 1998
Decision Date March 23, 1999
Days to Decision 166 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
18d slower than avg
Panel avg: 148d · This submission: 166d
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 113
Devices cleared under the same product code (GWQ) and FDA review panel - the closest regulatory comparables to K983533.
BRAVO MULTI-MODALITY SYSTEM
K991054 · Nicolet Biomedical, Inc. · Nov 1999
ACTITRAC
K992410 · Individual Monitoring Systems, Inc. · Oct 1999
ACTIWATCH-SCORE
K991033 · Mini-Mitter Co., Inc. · Jun 1999
EXCEL AMBULATORY EEG
K982479 · Excel Tech. , Ltd. · Oct 1998
EXCEL NEURO WORKS
K980214 · Excel Tech. , Ltd. · Apr 1998
BIO-LOGIC CEEGRAPH 128-CHANNEL RECORDING SYSTEM
K973883 · Bio-Logic Systems Corp. · Mar 1998