Cleared Special

K101386 - VIGILANT EEG MONITOR MODEL VIGILANT 2.0

K101386 is an FDA 510(k) clearance for VIGILANT EEG MONITOR MODEL VIGILANT 2.0, manufactured by Infinite Biomedical Technologies, LLC. The device is a Class 2 Neurology device with product code GWQ cleared through the Special 510(k) pathway after a 73-day FDA review.

K101386 · Infinite Biomedical Technologies, LLC · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2010
Decision
73d
Days
Class 2
Risk

K101386 is an FDA 510(k) clearance for the VIGILANT EEG MONITOR MODEL VIGILANT 2.0. Classified as Full-montage Standard Electroencephalograph (product code GWQ), Class II - Special Controls.

Submitted by Infinite Biomedical Technologies, LLC (Baltimore, US). The FDA issued a Cleared decision on July 30, 2010 after a review of 73 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 Infinite Biomedical Technologies, LLC devices

FDA 510(k) Submission Details - K101386

510(k) Number K101386 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 2010
Decision Date July 30, 2010
Days to Decision 73 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 149d · This submission: 73d
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.

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