# K091963: Vigilant Eeg Monitor, Vigilant 2.0

- Pathway: 510(k) (Traditional)
- Applicant: Infinite Biomedical Technologies, LLC
- Decided: Nov 6, 2009 after 128 days
- Product code: OLT (Non-Normalizing Quantitative Electroencephalograph Software)
- Device class: 2
- Regulation: 21 CFR 882.1400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K980214 (1998). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992313: XL Tek Evoked Potential Headbox, Model EP-16, Excel Tech., Ltd. (1999) Summary page 1.
- K980214: Excel Neuro  Works, Excel Tech., Ltd. (1998) Summary page 1.

## Indications for use
The Vigilant EEG Monitor (Vigilant 2.0) is an electroencephalograph that works in conjunction with Vigilant bedside monitoring and remote review software. It is intended for measuring and recording the electrical activity of a patient's brain by applying 8 electrodes on the head. The Vigilant EEG Monitor (Vigilant 2.0) requires competent user input, and its output must be reviewed and interpreted by trained medical professionals who will exercise professional judgment in using this information.

Source page: https://510kreport.com/device/K091963
Methodology: https://510kreport.com/methodology