510(k) · Cleared
ClearedUB ERP System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Universal Brain · OLT Non-Normalizing Quantitative Electroencephalograph Software
Cleared on Jun 30, 2026 as substantially equivalent to K192753 (Medeia, Inc., 2020) and 1 other predicate after a 217-day review. Its family tree reaches back 12 generations to 1987.
- Decided
- Jun 30, 2026
- Review
- 217 days
- Class
- Class II
- Product code
- OLT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 12 generations to K873535 (1987). 47 ancestors in all. No later device cites it as a predicate yet.
- Root · 12 generations backK873535 Nicolet Expert Sleep/Wake Analysis SystemNicolet Biomedical Instruments · 1987
- 8 generations between
- 3 generations backK171781 eVox SystemEvoke Neuroscience, Inc. · 2017
- 2 generations backK192753 NeuralScan SystemMedeia, Inc. · 2020
- 1 generation backK221963 Cumulus Functional Neurophysiology PlatformCumulus Neuroscience Limited · 2023
- This deviceK253767 UB ERP SystemUniversal Brain · 2026
Show all 12 generations
- Root · 12 generations backK873535 Nicolet Expert Sleep/Wake Analysis SystemNicolet Biomedical Instruments · 1987
- 11 generations backK955841 Sleep System for Clinics & ResearchCompumedics Ptd, Ltd. · 1997
- 10 generations backK072014 VitascoreVitascore B.V. · 2007
- 9 generations backK082968 Apneicare Connection Center/Internet AnalysisApneicare, LLC · 2009
- 8 generations backK112514 Apnea Risk Evaluation System (Ares)Advanced Brain Monitoring, Inc. · 2012
- 7 generations backK120447 X4Advanced Brain Monitoring, Inc. · 2012
- 6 generations backK130013 X4 SystemAdvanced Brain Monitoring, Inc. · 2013
- 5 generations backK131383 X10 Headset with X-Series Basic Software, X24 Headset with X-Series…Advanced Brain Monitoring, Inc. · 2013
- 4 generations backK141316 Cognision Eeg/EP SystemNeuronetrix Solutions · 2015
- 3 generations backK171781 eVox SystemEvoke Neuroscience, Inc. · 2017
- 2 generations backK192753 NeuralScan SystemMedeia, Inc. · 2020
- 1 generation backK221963 Cumulus Functional Neurophysiology PlatformCumulus Neuroscience Limited · 2023
- This deviceK253767 UB ERP SystemUniversal Brain · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K873535 | Nicolet Expert Sleep/Wake Analysis System | Nicolet Biomedical Instruments | 1987 | — |
| −11 | K955841 | Sleep System for Clinics & Research | Compumedics Ptd, Ltd. | 1997 | — |
| −10 | K072014 | Vitascore | Vitascore B.V. | 2007 | — |
| −9 | K082968 | Apneicare Connection Center/Internet Analysis | Apneicare, LLC | 2009 | — |
| −8 | K112514 | Apnea Risk Evaluation System (Ares) | Advanced Brain Monitoring, Inc. | 2012 | — |
| −7 | K120447 | X4 | Advanced Brain Monitoring, Inc. | 2012 | — |
| −6 | K130013 | X4 System | Advanced Brain Monitoring, Inc. | 2013 | — |
| −5 | K131383 | X10 Headset with X-Series Basic Software, X24 Headset with X-Series Basic… | Advanced Brain Monitoring, Inc. | 2013 | — |
| −4 | K141316 | Cognision Eeg/EP System | Neuronetrix Solutions | 2015 | — |
| −3 | K171781 | eVox System | Evoke Neuroscience, Inc. | 2017 | — |
| −2 | K192753 | NeuralScan System | Medeia, Inc. | 2020 | — |
| −1 | K221963 | Cumulus Functional Neurophysiology Platform | Cumulus Neuroscience Limited | 2023 | — |
| 0 (this device) | K253767 | UB ERP System | Universal Brain | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 2 | 0 |
| 1993 | 3 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 3 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2015 | 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 K254213 Pascall Sensor Unit (PSU1)score 14.6 · 10 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 |
|---|---|---|---|
| * | K192753 | NeuralScan SystemSummary page 5…: Class II Regulation Number: 21 CFR 882.1400 Product Code: OLT, GWJ, GWQ Primary Predicate Device NeuralScan System, Medeia, Inc., NeuralScan System, K192753 Secondary Predicate Device Cumulus Functional Neurophysiology Platform, Cumulus Neuroscience Limited, K2219… | 2020 |
| * | K221963 | Cumulus Functional Neurophysiology PlatformSummary page 5…tem, Medeia, Inc., NeuralScan System, K192753 Secondary Predicate Device Cumulus Functional Neurophysiology Platform, Cumulus Neuroscience Limited, K221963 Device Description The UB ERP System is an electroencephalography (EEG)-based device used to record, store… | 2023 |
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?
- The line of descent spans 39 years and passes through 10 companies; a new generation was cleared every 2.8 years on median.
- 3 of the 47 ancestors have a recall of any class.
- 2 other devices also cite its predicate K192753.
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. 2026, 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 UB ERP System is intended for the acquisition, display, analysis, storage and reporting of electrical activity of a patient’s brain, including electroencephalography (EEG) signals and event-related potentials (ERPs), obtained by placing two or more electrodes on the head of adults and adolescent patients to aid in diagnosis. The EEG signals are time-stamped. It is used with an UB EEG Cap loaded with appropriate software and connected to a Windows PC…
Read the full statement (131 words)
The UB ERP System is intended for the acquisition, display, analysis, storage and reporting of electrical activity of a patient’s brain, including electroencephalography (EEG) signals and event-related potentials (ERPs), obtained by placing two or more electrodes on the head of adults and adolescent patients to aid in diagnosis. The EEG signals are time-stamped. It is used with an UB EEG Cap loaded with appropriate software and connected to a Windows PC using a USB cable.
The UB ERP System is to be used in a health care facility or a clinic under the direction of a healthcare professional.
The UB ERP System does not draw any diagnostic conclusion. A clinical expert must interpret recorded EEG signals. The results of such interpretation should be considered only in conjunction with other clinical findings.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253767 · printed Nov 4, 2026
Cite this page
510(k) Report. “K253767: UB ERP System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K253767
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026