510(k) · Cleared
ClearedVigilant Eeg Monitor, Vigilant 2.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Infinite Biomedical Technologies, LLC · OLT Non-Normalizing Quantitative Electroencephalograph Software
Cleared on Nov 6, 2009 as substantially equivalent to K992313 (Excel Tech., Ltd., 1999) and 1 other predicate after a 128-day review. Its family tree reaches back 1 generation to 1998.
- Decided
- Nov 6, 2009
- Review
- 128 days
- Class
- Class II
- Product code
- OLT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K980214 (1998). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK980214 Excel Neuro WorksExcel Tech., Ltd. · 1998
- This deviceK091963 Vigilant Eeg Monitor, Vigilant 2.0Infinite Biomedical Technologies, LLC · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K980214 | Excel Neuro Works | Excel Tech., Ltd. | 1998 | — |
| 0 (this device) | K091963 | Vigilant Eeg Monitor, Vigilant 2.0 | Infinite Biomedical Technologies, LLC | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OLT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new OLT device
- #1 K253767 UB ERP Systemscore 14.9 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K992313 | XL Tek Evoked Potential Headbox, Model EP-16Summary page 1…on or Usual Name Electroencephalograph Classification Name Electroencephalograph (CFR 882.1400, Class II) Predicate Devices EXCEL TECH. LTD.'s Xltek EP-1 6 headbox (K9923 13) (Electroencephalograph, CFR 882.1400, GWQ) EXCEL TECH. LTD.'s NeuroWorks EEG (1K980214) (Electroencephalograph, CFR 882.1400, G… | 1999 |
| * | K980214 | Excel Neuro WorksSummary page 1…82.1400, Class II) Predicate Devices EXCEL TECH. LTD.'s Xltek EP-1 6 headbox (K9923 13) (Electroencephalograph, CFR 882.1400, GWQ) EXCEL TECH. LTD.'s NeuroWorks EEG (1K980214) (Electroencephalograph, CFR 882.1400, GWQ) Intended Use / Indications for Use The Vigilant EEG Monitor (Vigilant 2.0) is an el… | 1998 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 2 ancestors has a recall.
How does its category compare?
All OLT devicesOLT Non-Normalizing Quantitative Electroencephalograph Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · OLT
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OLT
266in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OLT
No recall names OLT since 2007.
Adverse event reports per year · OLT
3in 2025
MAUDE reports naming product code OLT, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 5 | 266 | 0 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 7 |
| 2019 | 2 | — | 0 | 2 |
| 2020 | 1 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 6 |
| 2022 | 2 | — | 0 | 4 |
| 2023 | 0 | — | 0 | 5 |
| 2024 | 1 | — | 0 | 4 |
| 2025 | 2 | — | 0 | 3 |
| 2026 | 3 | 217 | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091963 · printed Nov 6, 2026
Cite this page
510(k) Report. “K091963: Vigilant Eeg Monitor, Vigilant 2.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091963
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026