Cleared Special

ACTIWARE-PLMS (K011430) - FDA 510(k) Clearance

Class II Neurology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K011430 · Mini-Mitter Co., Inc. · Neurology device
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May 2001
Decision
22d
Days
Class 2
Risk

K011430 is an FDA 510(k) clearance for the ACTIWARE-PLMS. Classified as Full-montage Standard Electroencephalograph (product code GWQ), Class II - Special Controls.

Submitted by Mini-Mitter Co., Inc. (Bend, US). The FDA issued a Cleared decision on May 31, 2001 after a review of 22 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Mini-Mitter Co., Inc. devices

Submission Details

510(k) Number K011430 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 2001
Decision Date May 31, 2001
Days to Decision 22 days
Submission Type Special
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
126d faster than avg
Panel avg: 148d · This submission: 22d
Pathway characteristics
Modification to existing cleared device.

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 187
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