Cleared Traditional

K131335 - BWMINI EEG, BWMINIHST, BWMINI PSG

K131335 is an FDA 510(k) clearance for BWMINI EEG, manufactured by Neurovirtual USA, Inc.. The device is a Class 2 Neurology device with product code GWQ cleared through the Traditional 510(k) pathway after a 635-day FDA review.

K131335 · Neurovirtual USA, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2015
Decision
635d
Days
Class 2
Risk

K131335 is an FDA 510(k) clearance for the BWMINI EEG, BWMINIHST, BWMINI PSG. Classified as Full-montage Standard Electroencephalograph (product code GWQ), Class II - Special Controls.

Submitted by Neurovirtual USA, Inc. (Doral, US). The FDA issued a Cleared decision on February 3, 2015 after a review of 635 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Neurology submissions.

View all Neurovirtual USA, Inc. devices

FDA 510(k) Submission Details - K131335

510(k) Number K131335 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 2013
Decision Date February 03, 2015
Days to Decision 635 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
487d slower than avg
Panel avg: 148d · This submission: 635d
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 137
Devices cleared under the same product code (GWQ) and FDA review panel - the closest regulatory comparables to K131335.
Discovery 24
K150498 · Brainmaster Technologies, Inc. · Jan 2016
Mitsar-EEG
K143233 · Mitsar Co., Ltd. · Aug 2015
Natus Quantum
K143440 · Natus Medical Incorporated · Apr 2015
TREZ_HD
K131266 · Excel-Tech Ltd. (Xltek) · Feb 2014
CADWELL FLEX EEG/PSG
K133355 · Cadwell Industries, Inc. · Jan 2014
X10 HEADSET WITH X-SERIES BASIC SOFTWARE, X24 HEADSET WITH X-SERIES BASIC SOFTWARE
K131383 · Advanced Brain Monitoring, Inc. · Nov 2013