Cleared Special

K011430 - ACTIWARE-PLMS

K011430 is an FDA 510(k) clearance for ACTIWARE-PLMS, manufactured by Mini-Mitter Co., Inc.. The device is a Class 2 Neurology device with product code GWQ cleared through the Special 510(k) pathway after a 22-day FDA review.

K011430 · Mini-Mitter Co., Inc. · Neurology device
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Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K011430

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
127d faster than avg
Panel avg: 149d · This submission: 22d
Pathway characteristics
Modification to existing cleared device.

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 183
Devices cleared under the same product code (GWQ) and FDA review panel - the closest regulatory comparables to K011430.
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K010086 · Excel Tech. , Ltd. · Apr 2001
REAL PATIENT AMBULATORY EEG, MODEL EX-AMB-RP (PROPOSED)
K010088 · Excel Tech. , Ltd. · Mar 2001
REAL PATIENT WIRELESS AMBULATORY EEG, MODEL EX-AMB-WIRELESS-RP (PROPOSED)
K010089 · Excel Tech. , Ltd. · Mar 2001
K011430 · ACTIWARE-PLMS
Download PDF Mini-Mitter Co., Inc.