510(k) · Cleared
ClearedOlympic Brainz Monitor Model OBM70001
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Natus Medical, Inc. · OMA Amplitude-Integrated Electroencephalograph
Cleared on Jun 16, 2010 after a 175-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 2 later devices descend from it.
- Decided
- Jun 16, 2010
- Review
- 175 days
- Class
- Class II
- Product code
- OMA
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
- This deviceK093949 Olympic Brainz Monitor Model OBM70001Natus Medical, Inc. · 2010
- Descendant · cites it directly · 0 of its ownK192889 NeoEemagine Medical Imaging Solutions GmbH · 2020
- Descendant · cites it directly · 0 of its ownK123079 Olympic Brainz MonitorExcel-Tech Ltd. (Xltek) · 2013 · Recalled
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 |
|---|---|---|---|---|---|
| 0 (this device) | K093949 | Olympic Brainz Monitor Model OBM70001 | Natus Medical, Inc. | 2010 | — |
| +1 | K192889 | Neo | Eemagine Medical Imaging Solutions GmbH | 2020 | — |
| +1 | K123079 | Olympic Brainz Monitor | Excel-Tech Ltd. (Xltek) | 2013 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2020 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (2)
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?
- Of its descendants, K192889 (Eemagine Medical Imaging Solutions GmbH, 2020) has gone furthest, with 0 descendants of its own.
How does its category compare?
All OMA devicesOMA Amplitude-Integrated Electroencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 Olympic Brainz Monitor (OR3M) is a three channel electroencephalograph (EEG) acquisition system intended to be used in a hospital environment to record, collect, display and facilitate manual marking of aEEG recordings. • The signals acquired from P3-P4, 03-P3 and C4-P4 channels are intended for use only with neonatal patients (defined as from birth to 28 days post delivery, and corresponding to a post-conceptual age of 24 to 46 weeks) to display…
Read the full statement (132 words)
The Olympic Brainz Monitor (OR3M) is a three channel electroencephalograph (EEG) acquisition system intended to be used in a hospital environment to record, collect, display and facilitate manual marking of aEEG recordings.
• The signals acquired from P3-P4, 03-P3 and C4-P4 channels are intended for use only with neonatal patients (defined as from birth to 28 days post delivery, and corresponding to a post-conceptual age of 24 to 46 weeks) to display aEEG for monitoring the state of the brain.
• The signals acquired from P3-P4 channel is intended to assist in the prediction of and severity of Hypoxic-lschemnic Encephalopathy and long-term outcome in full term neonates (post-conceptual age of 37-46 weeks) who have suffered a hypoxic-ischemic event.
The Olympic Brainz Monitor does not provide any diagnostic conclusion about the patient's condition.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K093949 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093949: Olympic Brainz Monitor Model OBM70001.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093949
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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