510(k) · Cleared
ClearedBRC Software Product
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Brc Operations Pty Limited · OLU Normalizing Quantitative Electroencephalograph Software
Cleared on Oct 20, 2005 as substantially equivalent to K974748 (Nxlink, Ltd., 1998) and 2 other predicates after a 266-day review. Its family tree reaches back 3 generations to 1980. 4 later devices descend from it.
- Decided
- Oct 20, 2005
- Review
- 266 days
- Class
- Class II
- Product code
- OLU
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K801604 (1980). 17 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK801604 Pathfinder Electrodiagnostic SystemNicolet Biomedical Instruments · 1980
- 2 generations backK974748 Neurometric Analysis SystemNxlink, Ltd. · 1998
- 1 generation backK041263 Neuroguide Analysis SystemApplied Neuroscience, Inc. · 2004
- This deviceK050192 BRC Software ProductBrc Operations Pty Limited · 2005
- Descendant · cites it directly · 3 of its ownK112077 Hbidb - Human Brian Index SoftwareCorscience GmbH & Co. KG · 2012
- Descendant · cites it directly · 2 of its ownK121119 Bna Analysis SystemEiminda, Ltd. · 2014
- Descendant · 2 generations on · 1 of its ownK202588 BNA PlatformElminda, Ltd. · 2020
- Descendant · 3 generations on · 0 of its ownK253015 Cognitive Function Neuroimaging (cfNI) Software (1.0.0)VoxNeuro, Inc. · 2026
Most influential descendants
Showing 4 of 4 · See all- K112077Hbidb - Human Brian Index SoftwareCorscience GmbH & Co. KG · 2012 · cites it directly3descendants
- K121119Bna Analysis SystemEiminda, Ltd. · 2014 · cites it directly2descendants
- K202588BNA PlatformElminda, Ltd. · 2020 · 2 generations on1descendant
- K253015Cognitive Function Neuroimaging (cfNI) Software (1.0.0)VoxNeuro, Inc. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K801604 | Pathfinder Electrodiagnostic System | Nicolet Biomedical Instruments | 1980 | — |
| −2 | K974748 | Neurometric Analysis System | Nxlink, Ltd. | 1998 | — |
| −1 | K041263 | Neuroguide Analysis System | Applied Neuroscience, Inc. | 2004 | — |
| 0 (this device) | K050192 | BRC Software Product | Brc Operations Pty Limited | 2005 | — |
| +1 | K112077 | Hbidb - Human Brian Index Software | Corscience GmbH & Co. KG | 2012 | — |
| +1 | K121119 | Bna Analysis System | Eiminda, Ltd. | 2014 | — |
| +2 | K202588 | BNA Platform | Elminda, Ltd. | 2020 | — |
| +3 | 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 |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K974748 | Neurometric Analysis SystemSummary page 1…Number: 882.1400 807.92(a)(3) Predicate Device(s) Neurometric Analysis K974748 System Nxlink, Ltd K010669 NeuroGraph… | 1998 |
| * | K010669 | Neurograph Evoked Potential Systems (Eps), Model Eps-1Summary page 1…dicate Device(s) Neurometric Analysis K974748 System Nxlink, Ltd K010669 NeuroGraph Thuris Corp. K041263 NeuroGuide A… | 2001 |
| * | K041263 | Neuroguide Analysis SystemSummary page 1…K974748 System Nxlink, Ltd K010669 NeuroGraph Thuris Corp. K041263 NeuroGuide Applied Neuroscience 510(k) Summiary BRC Operations Ply. Ltd.… | 2004 |
What descends from it? (4)
2 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 25 years and passes through 4 companies; a new generation was cleared every 6.1 years on median.
- None of the 17 ancestors has a recall.
- Of its descendants, K112077 (Corscience GmbH & Co. KG, 2012) has gone furthest, with 3 descendants of its own.
- 3 other devices also cite its predicate K974748.
How does its category compare?
All OLU devicesOLU Normalizing Quantitative Electroencephalograph Software: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 BRC software product is to be used by qualified medical professionals for the post-hoc statistical evaluation of the human electroencephalogram (EEG), utilizing evoked response potentials (ERP).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050192 · printed Nov 5, 2026
Cite this page
510(k) Report. “K050192: BRC Software Product.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K050192
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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