510(k) · Cleared
ClearedBna Analysis System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eiminda, Ltd. · OLU Normalizing Quantitative Electroencephalograph Software
Cleared on Jul 25, 2014 as substantially equivalent to K041263 (Applied Neuroscience, Inc., 2004) and 2 other predicates after an 834-day review. Its family tree reaches back 5 generations to 1980. 2 later devices descend from it.
- Decided
- Jul 25, 2014
- Review
- 834 days
- Class
- Class II
- Product code
- OLU
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K801604 (1980). 19 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK801604 Pathfinder Electrodiagnostic SystemNicolet Biomedical Instruments · 1980
- 4 generations backK974748 Neurometric Analysis SystemNxlink, Ltd. · 1998
- 3 generations backK041263 Neuroguide Analysis SystemApplied Neuroscience, Inc. · 2004
- 2 generations backK050192 BRC Software ProductBrc Operations Pty Limited · 2005
- 1 generation backK112077 Hbidb - Human Brian Index SoftwareCorscience GmbH & Co. KG · 2012
- This deviceK121119 Bna Analysis SystemEiminda, Ltd. · 2014
- Descendant · cites it directly · 1 of its ownK202588 BNA PlatformElminda, Ltd. · 2020
- Descendant · 2 generations on · 0 of its ownK253015 Cognitive Function Neuroimaging (cfNI) Software (1.0.0)VoxNeuro, Inc. · 2026
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K801604 | Pathfinder Electrodiagnostic System | Nicolet Biomedical Instruments | 1980 | — |
| −4 | K974748 | Neurometric Analysis System | Nxlink, Ltd. | 1998 | — |
| −3 | K041263 | Neuroguide Analysis System | Applied Neuroscience, Inc. | 2004 | — |
| −2 | K050192 | BRC Software Product | Brc Operations Pty Limited | 2005 | — |
| −1 | K112077 | Hbidb - Human Brian Index Software | Corscience GmbH & Co. KG | 2012 | — |
| 0 (this device) | K121119 | Bna Analysis System | Eiminda, Ltd. | 2014 | — |
| +1 | K202588 | BNA Platform | Elminda, Ltd. | 2020 | — |
| +2 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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 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? (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 |
|---|---|---|---|
| * | K041263 | Neuroguide Analysis SystemSummary page 1…ification Name Electroencephalogram ("EEG") Regulation Number .882.1400 Product Code OLU Predicate Devices Neuroguide Analysis System (K041263) Neuromarker Data Acquisition and Analysis Software (K050192) Human Brain Index Software (K1 12077) Intended Use /… | 2004 |
| * | K050192 | BRC Software ProductSummary page 1…er .882.1400 Product Code OLU Predicate Devices Neuroguide Analysis System (K041263) Neuromarker Data Acquisition and Analysis Software (K050192) Human Brain Index Software (K1 12077) Intended Use / Indications for Use The BNATM Analysis System is to be used by qua… | 2005 |
| * | K112077 | Hbidb - Human Brian Index SoftwareSummary page 1…LU Predicate Devices Neuroguide Analysis System (K041263) Neuromarker Data Acquisition and Analysis Software (K050192) Human Brain Index Software (K1 12077) Intended Use / Indications for Use The BNATM Analysis System is to be used by qualified medical professionals for the post- ho… | 2012 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K202588 | BNA Platform | 2020 | 1 |
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 34 years and passes through 6 companies; a new generation was cleared every 6.1 years on median.
- None of the 19 ancestors has a recall.
- Of its descendants, K202588 (Elminda, Ltd., 2020) has gone furthest, with 1 descendant of its own.
- 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. 2014, 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 BNA Analysis System is to be used by qualified medical professionals for the post-hoc statistical analysis of the human electroencephalogram ("EEG"), utilizing evoked response potentials ("ERP"). This device is indicated for use in individuals 14 to 24 years of age. The BNA Analysis System is to be used with the auditory oddball task only.
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/K121119 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121119: Bna Analysis System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121119
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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