510(k) · Cleared
ClearedNeuroField Analysis Suite
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neurofield, Inc. · OLU Normalizing Quantitative Electroencephalograph Software
Cleared on Sep 20, 2024 as substantially equivalent to K041263 (Applied Neuroscience, Inc., 2004) and 1 other predicate after a 220-day review. Its family tree reaches back 10 generations to 1987.
- Decided
- Sep 20, 2024
- Review
- 220 days
- Class
- Class II
- Product code
- OLU
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K873535 (1987). 61 ancestors in all, the oldest K801604 (1980). No later device cites it as a predicate yet.
- Root · 10 generations backK873535 Nicolet Expert Sleep/Wake Analysis SystemNicolet Biomedical Instruments · 1987
- 6 generations between
- 3 generations backK131383 X10 Headset with X-Series Basic Software, X24 Headset with X-Series…Advanced Brain Monitoring, Inc. · 2013
- 2 generations backK141316 Cognision Eeg/EP SystemNeuronetrix Solutions · 2015
- 1 generation backK171781 eVox SystemEvoke Neuroscience, Inc. · 2017
- This deviceK240420 NeuroField Analysis SuiteNeurofield, Inc. · 2024
Show all 10 generations
- Root · 10 generations backK873535 Nicolet Expert Sleep/Wake Analysis SystemNicolet Biomedical Instruments · 1987
- 9 generations backK955841 Sleep System for Clinics & ResearchCompumedics Ptd, Ltd. · 1997
- 8 generations backK072014 VitascoreVitascore B.V. · 2007
- 7 generations backK082968 Apneicare Connection Center/Internet AnalysisApneicare, LLC · 2009
- 6 generations backK112514 Apnea Risk Evaluation System (Ares)Advanced Brain Monitoring, Inc. · 2012
- 5 generations backK120447 X4Advanced Brain Monitoring, Inc. · 2012
- 4 generations backK130013 X4 SystemAdvanced Brain Monitoring, Inc. · 2013
- 3 generations backK131383 X10 Headset with X-Series Basic Software, X24 Headset with X-Series…Advanced Brain Monitoring, Inc. · 2013
- 2 generations backK141316 Cognision Eeg/EP SystemNeuronetrix Solutions · 2015
- 1 generation backK171781 eVox SystemEvoke Neuroscience, Inc. · 2017
- This deviceK240420 NeuroField Analysis SuiteNeurofield, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K873535 | Nicolet Expert Sleep/Wake Analysis System | Nicolet Biomedical Instruments | 1987 | — |
| −9 | K955841 | Sleep System for Clinics & Research | Compumedics Ptd, Ltd. | 1997 | — |
| −8 | K072014 | Vitascore | Vitascore B.V. | 2007 | — |
| −7 | K082968 | Apneicare Connection Center/Internet Analysis | Apneicare, LLC | 2009 | — |
| −6 | K112514 | Apnea Risk Evaluation System (Ares) | Advanced Brain Monitoring, Inc. | 2012 | — |
| −5 | K120447 | X4 | Advanced Brain Monitoring, Inc. | 2012 | — |
| −4 | K130013 | X4 System | Advanced Brain Monitoring, Inc. | 2013 | — |
| −3 | K131383 | X10 Headset with X-Series Basic Software, X24 Headset with X-Series Basic… | Advanced Brain Monitoring, Inc. | 2013 | — |
| −2 | K141316 | Cognision Eeg/EP System | Neuronetrix Solutions | 2015 | — |
| −1 | K171781 | eVox System | Evoke Neuroscience, Inc. | 2017 | — |
| 0 (this device) | K240420 | NeuroField Analysis Suite | Neurofield, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1985 | 3 | 0 |
| 1986 | 2 | 0 |
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 3 | 0 |
| 1991 | 5 | 0 |
| 1992 | 2 | 0 |
| 1993 | 3 | 0 |
| 1995 | 3 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 3 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 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 OLU? 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 OLU device
- #1 K253015 Cognitive Function Neuroimaging (cfNI)…score 13.3 · 7 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 |
|---|---|---|---|
| * | K041263 | Neuroguide Analysis SystemSummary page 5…n: 21 CFR 882.1400 Product Class: Class II Legally Marketed Predicate Device 510(k) Product Code Trade Name Applicant K041263 OLU NeuroGuide Applied Neuroscience, Inc. Analysis System 228 176th T… | 2004 |
| * | K171781 | eVox SystemSummary page 5…St. Petersburg, Florida 33708 Legally Marketed Secondary Predicate Device 510(k) Product Code Trade Name Applicant K171781 GWJ eVox System Evoke Neuroscience, Inc. 200 Valencia… | 2017 |
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 37 years and passes through 8 companies; a new generation was cleared every 2.8 years on median.
- 3 of the 61 ancestors have a recall of any class.
- 8 other devices also cite its predicate K041263.
How does its category compare?
All OLU devicesOLU Normalizing Quantitative Electroencephalograph Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · OLU
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · OLU
Too few OLU 510(k)s in any year since 2007 to give a median.
Recalls per year · OLU
No recall names OLU since 2007.
Adverse event reports per year · OLU
1in 2025
MAUDE reports naming product code OLU, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The NeuroField Analysis Suite is to be used by qualified medical and qualified clinical professionals for the display and storage of electrical activity of a patient’s brain, including the post-hoc statistical evaluation of the human electroencephalogram (EEG) and event-related potentials (ERP).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240420 · printed Nov 6, 2026
Cite this page
510(k) Report. “K240420: NeuroField Analysis Suite.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K240420
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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