510(k) · Cleared
Recalled · Class II · 2025Olympic Brainz Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Excel-Tech Ltd. (Xltek) · OMA Amplitude-Integrated Electroencephalograph
Cleared on May 8, 2013 as substantially equivalent to K093949 (Natus Medical, Inc., 2010) and 2 other predicates after a 219-day review. Its family tree reaches back 4 generations to 1980. It has been recalled 2 times.
- Decided
- May 8, 2013
- Review
- 219 days
- Class
- Class II
- Product code
- OMA
- Recalls
- 2
- Predicates
- 3
Its longest line of descent runs back 4 generations to K801604 (1980). 19 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK801604 Pathfinder Electrodiagnostic SystemNicolet Biomedical Instruments · 1980
- 3 generations backK974748 Neurometric Analysis SystemNxlink, Ltd. · 1998
- 2 generations backK041263 Neuroguide Analysis SystemApplied Neuroscience, Inc. · 2004
- 1 generation backK092039 Identevent, Version 1.0GOptima Neuroscience, Inc. · 2009
- This deviceK123079 Olympic Brainz MonitorExcel-Tech Ltd. (Xltek) · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K801604 | Pathfinder Electrodiagnostic System | Nicolet Biomedical Instruments | 1980 | — |
| −3 | K974748 | Neurometric Analysis System | Nxlink, Ltd. | 1998 | — |
| −2 | K041263 | Neuroguide Analysis System | Applied Neuroscience, Inc. | 2004 | — |
| −1 | K092039 | Identevent, Version 1.0G | Optima Neuroscience, Inc. | 2009 | — |
| 0 (this device) | K123079 | Olympic Brainz Monitor | Excel-Tech Ltd. (Xltek) | 2013 | — |
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 |
| 2010 | 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? (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 |
|---|---|---|---|
| * | K093949 | Olympic Brainz Monitor Model OBM70001Summary page 1…Electroencephalograph, Reduced- Montage Standard Electroencephalograph Product code: OMA, OMB, OMO Device Class: 11 Predicate Devices: Olympic Brainz Monitor (K093949) IndenEvent (K092039) Persyst Reveal (K01 1397) The Olympic Brainz Monitor1 is a thre… | 2010 |
| * | K092039 | Identevent, Version 1.0GSummary page 1…andard Electroencephalograph Product code: OMA, OMB, OMO Device Class: 11 Predicate Devices: Olympic Brainz Monitor (K093949) IndenEvent (K092039) Persyst Reveal (K01 1397) The Olympic Brainz Monitor1 is a three-channel electroencephalograph (EEG) syst… | 2009 |
| * | K011397 | Persyst RevealSummary page 1…: OMA, OMB, OMO Device Class: 11 Predicate Devices: Olympic Brainz Monitor (K093949) IndenEvent (K092039) Persyst Reveal (K01 1397) The Olympic Brainz Monitor1 is a three-channel electroencephalograph (EEG) system, as per 21 CFR §882.1400: a device used to m… | 2001 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 7, 2025 | Class II | Z-1925-2025 | Employee error | Electrode placement labels on the Digital Acquisition Box (DAB) were applied backwards. This may ultimately lead to misdiagnosis of seizure location in neonates monitored with this device. |
| Mar 5, 2020 | Class II | Z-1630-2020 | Nonconforming Material/Component | The OBM system functional test (impedance and noise) was not carried out on the affected items prior to release to the customer. The manufacturer cannot attest to the system functionality of the affected items. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 33 years and passes through 5 companies; a new generation was cleared every 6.1 years on median.
- None of the 19 ancestors has a recall.
- 1 other device also cites its predicate K093949.
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 Olympic Brainz Monitor (OBM) 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 aFEG recordings. The signals acquired from P3-P4, C3-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 postconceptual age of 24 to 46 weeks) to display aEEG…
Read the full statement (222 words)
The Olympic Brainz Monitor (OBM) 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 aFEG recordings.
The signals acquired from P3-P4, C3-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 postconceptual 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 assessment of Hypoxic-lschemic Encephalopathy severity and long-term outcome, in full term neonates (postconceptual age of 37-46 weeks) who have suffered a hypoxic-ischemic event.
The RecogniZe seizure detection algorithm is intended to mark sections of EEG/aEEG that may correspond to electrographic seizures in only the centro-parietal regions of frill term neonates (defined as from birth to 28 days post-delivery, and corresponding to a postconceptual age of 37 to 46 weeks). EEG recordings should be obtained from centro-parietal electrodes (located at P3, P4, C3 and C4 according to 10/20 system). The output of the Recognize algorithm is intended to assist in post hoc assessment of EEG/aEEG traces by qualified clinical practitioners, who will exercise professional judgment in using the information.
The Olympic Brainz Monitor does not provide any diagnostic conclusion about the patient's condition.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123079 · printed Nov 5, 2026
Cite this page
510(k) Report. “K123079: Olympic Brainz Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K123079
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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