510(k) · Cleared
ClearedCognitive Function Neuroimaging (cfNI) Software (1.0.0)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
VoxNeuro, Inc. · OLU Normalizing Quantitative Electroencephalograph Software
Cleared on Jun 12, 2026 as substantially equivalent to K202588 (Elminda, Ltd., 2020) after a 266-day review. Its family tree reaches back 7 generations to 1980.
- Decided
- Jun 12, 2026
- Review
- 266 days
- Class
- Class II
- Product code
- OLU
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K801604 (1980). 22 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK801604 Pathfinder Electrodiagnostic SystemNicolet Biomedical Instruments · 1980
- 6 generations backK974748 Neurometric Analysis SystemNxlink, Ltd. · 1998
- 5 generations backK041263 Neuroguide Analysis SystemApplied Neuroscience, Inc. · 2004
- 4 generations backK050192 BRC Software ProductBrc Operations Pty Limited · 2005
- 3 generations backK112077 Hbidb - Human Brian Index SoftwareCorscience GmbH & Co. KG · 2012
- 2 generations backK121119 Bna Analysis SystemEiminda, Ltd. · 2014
- 1 generation backK202588 BNA PlatformElminda, Ltd. · 2020
- This deviceK253015 Cognitive Function Neuroimaging (cfNI) Software (1.0.0)VoxNeuro, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K801604 | Pathfinder Electrodiagnostic System | Nicolet Biomedical Instruments | 1980 | — |
| −6 | K974748 | Neurometric Analysis System | Nxlink, Ltd. | 1998 | — |
| −5 | K041263 | Neuroguide Analysis System | Applied Neuroscience, Inc. | 2004 | — |
| −4 | K050192 | BRC Software Product | Brc Operations Pty Limited | 2005 | — |
| −3 | K112077 | Hbidb - Human Brian Index Software | Corscience GmbH & Co. KG | 2012 | — |
| −2 | K121119 | Bna Analysis System | Eiminda, Ltd. | 2014 | — |
| −1 | K202588 | BNA Platform | Elminda, Ltd. | 2020 | — |
| 0 (this device) | K253015 | Cognitive Function Neuroimaging (cfNI) Software (1.0.0) | VoxNeuro, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 3 | 0 |
| 1986 | 2 | 0 |
| 1987 | 1 | 0 |
| 1989 | 2 | 0 |
| 1991 | 3 | 0 |
| 1995 | 2 | 0 |
| 2001 | 1 | 0 |
| 2018 | 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 K240420 NeuroField Analysis Suitescore 10.7 · 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? (1)
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 |
|---|---|---|---|
| * | K202588 | BNA PlatformSummary page 5…Regulation Number: 21 CFR 882.1400 Regulatory Class: Class II Product Code: OLU 3.PREDICATE DEVICE Predicate Device: BNA Platform (K202588) Firefly Neuroscience; formerly elminda Ltd. R1_CFNI-1.0.1 Page 1 o… | 2020 |
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 46 years and passes through 8 companies; a new generation was cleared every 6.1 years on median.
- None of the 22 ancestors has a recall.
How does its category compare?
All OLU devicesOLU 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 · 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 Cognitive Function Neuroimaging (cfNI) software is to be used by qualified healthcare professionals for the digital post-hoc statistical analysis of the human electroencephalogram (“EEG”), including event-related potentials (“ERPs”). This device is indicated for use in individuals 18 to 70 years of age, and in conjunction with Resting State, Auditory Oddball, Go No-Go, Continuous Visual Memory Test, and Eriksen Flanker tasks.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K253015 · printed Nov 5, 2026
Cite this page
510(k) Report. “K253015: Cognitive Function Neuroimaging (cfNI) Software (1.0.0).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K253015
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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