510(k) · Cleared
ClearedCerebralogik- Aeeg
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mennen Medical, Ltd. · OMA Amplitude-Integrated Electroencephalograph
Cleared on Dec 27, 2013 as substantially equivalent to K031149 (Olympic Medical Corp., 2003) after a 192-day review. Its family tree reaches back 5 generations to 1996. 1 later device descends from it.
- Decided
- Dec 27, 2013
- Review
- 192 days
- Class
- Class II
- Product code
- OMA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K963644 (1996). 7 ancestors in all, the oldest K791580 (1979). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK963644 A-1000 Eeg Monitor and a-1050 Eeg MonitorAspect Medical Systems, Inc. · 1996
- 4 generations backK973596 Spacelabs Medical 90482 Bispectral Index Analysis (Bis) ModuleSpacelabs Medical, Inc. · 1998
- 3 generations backK983229 Olympic Medical Lectromed Cerebral Function Monitor SystemOlympic Medical Corp. · 1999
- 2 generations backK020335 Olympic Medical Lectromed Cerebral Function Monitor System, Model 5330Olympic Medical Corp. · 2002
- 1 generation backK031149 Olympic CFM 6000Olympic Medical Corp. · 2003
- This deviceK131789 Cerebralogik- AeegMennen Medical, Ltd. · 2013
- Descendant · cites it directly · 0 of its ownK130238 Nihon Kohden AE-918P Neuro UnitNihon Kohden Corp. · 2015
Most influential descendants
Showing 1 of 1 · See all- K130238Nihon Kohden AE-918P Neuro UnitNihon Kohden Corp. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K963644 | A-1000 Eeg Monitor and a-1050 Eeg Monitor | Aspect Medical Systems, Inc. | 1996 | — |
| −4 | K973596 | Spacelabs Medical 90482 Bispectral Index Analysis (Bis) Module | Spacelabs Medical, Inc. | 1998 | — |
| −3 | K983229 | Olympic Medical Lectromed Cerebral Function Monitor System | Olympic Medical Corp. | 1999 | — |
| −2 | K020335 | Olympic Medical Lectromed Cerebral Function Monitor System, Model 5330 | Olympic Medical Corp. | 2002 | — |
| −1 | K031149 | Olympic CFM 6000 | Olympic Medical Corp. | 2003 | — |
| 0 (this device) | K131789 | Cerebralogik- Aeeg | Mennen Medical, Ltd. | 2013 | — |
| +1 | K130238 | Nihon Kohden AE-918P Neuro Unit | Nihon Kohden Corp. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 OMA? 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 OMA device
- #1 K192889 Neoscore -1.2 · 1 generation · no Class I recall
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 |
|---|---|---|---|
| * | K031149 | Olympic CFM 6000Summary page 2…raL-ogik module. The user will be able, in addition to existing capabilities, to also measure EEG signals and displays aEEG history. Predicate Device Olympic CFM 6000 -K031149, cleared May, 14, 2003 1. Device Description: CerebraLogik The CerebraLogik consists of a dual channel EEG amplifier… | 2003 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K130238 | Nihon Kohden AE-918P Neuro Unit | 2015 | 0 |
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 17 years and passes through 4 companies; a new generation was cleared every 1.3 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K130238 (Nihon Kohden Corp., 2015) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K031149.
How does its category compare?
All OMA devicesOMA Amplitude-Integrated Electroencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · OMA
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · OMA
Too few OMA 510(k)s in any year since 2007 to give a median.
Recalls per year · OMA
No recall names OMA since 2007.
Adverse event reports per year · OMA
2in 2024
MAUDE reports naming product code OMA, 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 | 0 | — | 0 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 2 | — | 0 | 1 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The intended use of the CerebraLogik is to monitor the state of the brain by acquisition of EEG signals and display the stored EEG in a compressed form of Amplitude Integrated EEG - sEEG and in conjunction with other clinical data.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131789 · printed Nov 5, 2026
Cite this page
510(k) Report. “K131789: Cerebralogik- Aeeg.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K131789
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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