Cleared Traditional

K091963 - VIGILANT EEG MONITOR, VIGILANT 2.0

K091963 is an FDA 510(k) clearance for VIGILANT EEG MONITOR, manufactured by Infinite Biomedical Technologies, LLC. The device is a Class 2 Neurology device with product code OLT cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K091963 · Infinite Biomedical Technologies, LLC · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2009
Decision
128d
Days
Class 2
Risk

K091963 is an FDA 510(k) clearance for the VIGILANT EEG MONITOR, VIGILANT 2.0. Classified as Non-normalizing Quantitative Electroencephalograph Software (product code OLT), Class II - Special Controls.

Submitted by Infinite Biomedical Technologies, LLC (Baltimore, US). The FDA issued a Cleared decision on November 6, 2009 after a review of 128 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K091963

510(k) Number K091963 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2009
Decision Date November 06, 2009
Days to Decision 128 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
21d faster than avg
Panel avg: 149d · This submission: 128d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OLT Device Classification - Class 2, Special Controls

Product Code OLT Non-normalizing Quantitative Electroencephalograph Software
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1400
Definition Analyze Electroencephalograph Data Using Conventional Methodology To Output And Display Standard Electroencephalograph Parameters For Interpretation By A Qualified User.
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 - OLT Non-normalizing Quantitative Electroencephalograph Software

All 45
Devices cleared under the same product code (OLT) and FDA review panel - the closest regulatory comparables to K091963.
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