510(k) · Cleared
ClearedCognision Eeg/EP System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neuronetrix Solutions · OLT Non-Normalizing Quantitative Electroencephalograph Software
Cleared on Feb 13, 2015 as substantially equivalent to K131383 (Advanced Brain Monitoring, Inc., 2013) and 2 other predicates after a 269-day review. Its family tree reaches back 8 generations to 1987. 7 later devices descend from it.
- Decided
- Feb 13, 2015
- Review
- 269 days
- Class
- Class II
- Product code
- OLT
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K873535 (1987). 38 ancestors in all. 7 later devices descend from it, 3 citing it directly.
- Root · 8 generations backK873535 Nicolet Expert Sleep/Wake Analysis SystemNicolet Biomedical Instruments · 1987
- 7 generations backK955841 Sleep System for Clinics & ResearchCompumedics Ptd, Ltd. · 1997
- 6 generations backK072014 VitascoreVitascore B.V. · 2007
- 5 generations backK082968 Apneicare Connection Center/Internet AnalysisApneicare, LLC · 2009
- 4 generations backK112514 Apnea Risk Evaluation System (Ares)Advanced Brain Monitoring, Inc. · 2012
- 3 generations backK120447 X4Advanced Brain Monitoring, Inc. · 2012
- 2 generations backK130013 X4 SystemAdvanced Brain Monitoring, Inc. · 2013
- 1 generation backK131383 X10 Headset with X-Series Basic Software, X24 Headset with X-Series…Advanced Brain Monitoring, Inc. · 2013
- This deviceK141316 Cognision Eeg/EP SystemNeuronetrix Solutions · 2015
- Descendant · cites it directly · 6 of its ownK171781 eVox SystemEvoke Neuroscience, Inc. · 2017
- Descendant · cites it directly · 3 of its ownK192753 NeuralScan SystemMedeia, Inc. · 2020
- Descendant · 2 generations on · 1 of its ownK221963 Cumulus Functional Neurophysiology PlatformCumulus Neuroscience Limited · 2023
- Descendant · 2 generations on · 0 of its ownK253767 UB ERP SystemUniversal Brain · 2026
- Descendant · 2 generations on · 0 of its ownK240420 NeuroField Analysis SuiteNeurofield, Inc. · 2024
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K171781eVox SystemEvoke Neuroscience, Inc. · 2017 · cites it directly6descendants
- K192753NeuralScan SystemMedeia, Inc. · 2020 · cites it directly3descendants
- K221963Cumulus Functional Neurophysiology PlatformCumulus Neuroscience Limited · 2023 · 2 generations on1descendant
- K253767UB ERP SystemUniversal Brain · 2026 · 2 generations on0descendants
- K240420NeuroField Analysis SuiteNeurofield, Inc. · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K873535 | Nicolet Expert Sleep/Wake Analysis System | Nicolet Biomedical Instruments | 1987 | — |
| −7 | K955841 | Sleep System for Clinics & Research | Compumedics Ptd, Ltd. | 1997 | — |
| −6 | K072014 | Vitascore | Vitascore B.V. | 2007 | — |
| −5 | K082968 | Apneicare Connection Center/Internet Analysis | Apneicare, LLC | 2009 | — |
| −4 | K112514 | Apnea Risk Evaluation System (Ares) | Advanced Brain Monitoring, Inc. | 2012 | — |
| −3 | K120447 | X4 | Advanced Brain Monitoring, Inc. | 2012 | — |
| −2 | K130013 | X4 System | Advanced Brain Monitoring, Inc. | 2013 | — |
| −1 | K131383 | X10 Headset with X-Series Basic Software, X24 Headset with X-Series Basic… | Advanced Brain Monitoring, Inc. | 2013 | — |
| 0 (this device) | K141316 | Cognision Eeg/EP System | Neuronetrix Solutions | 2015 | — |
| +1 | K171781 | eVox System | Evoke Neuroscience, Inc. | 2017 | — |
| +1 | K192753 | NeuralScan System | Medeia, Inc. | 2020 | — |
| +2 | K221963 | Cumulus Functional Neurophysiology Platform | Cumulus Neuroscience Limited | 2023 | — |
| +2 | K253767 | UB ERP System | Universal Brain | 2026 | — |
| +2 | K240420 | NeuroField Analysis Suite | Neurofield, Inc. | 2024 | — |
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 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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? (3)
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 |
|---|---|---|---|
| * | K131383 | X10 Headset with X-Series Basic Software, X24 Headset with X-Series Basic SoftwareSummary page 4…Device Class: All product codes utilized are considered Class II Classification Panel: Neurology 5. Legally Marketed Predicate Device(s) K131383 Advanced Brain Monitoring X-10/X-24 family K112052 CareFusion Nicolet EDX 2/ Viking Software K962447 Physiometr… | 2013 |
| * | K112052 | Carefusion Nicolet EdxSummary page 4…are considered Class II Classification Panel: Neurology 5. Legally Marketed Predicate Device(s) K131383 Advanced Brain Monitoring X-10/X-24 family K112052 CareFusion Nicolet EDX 2/ Viking Software K962447 Physiometrix Equinox Digital EEG System 6. Device Description… | 2012 |
| * | K962447 | Equinox Digital Eeg SystemSummary page 4…Neurology 5. Legally Marketed Predicate Device(s) K131383 Advanced Brain Monitoring X-10/X-24 family K112052 CareFusion Nicolet EDX 2/ Viking Software K962447 Physiometrix Equinox Digital EEG System 6. Device Description Page 5… | 1996 |
What descends from it? (7)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 28 years and passes through 6 companies; a new generation was cleared every 1.2 years on median.
- 2 of the 38 ancestors have a recall of any class.
- Of its descendants, K171781 (Evoke Neuroscience, Inc., 2017) has gone furthest, with 6 descendants of its own.
- 4 other devices also cite its predicate K131383.
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. 2015, 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 COGNISION System is for use by qualified clinical professionals in private practice offices or small clinical settings
for the acquisition, display, analysis, storage, reporting and management of electroencephalograph (EEG) and auditory
evoked potentials (AEP) information.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141316 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141316: Cognision Eeg/EP System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141316
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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