# K123079: Olympic Brainz Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Excel-Tech Ltd. (Xltek)
- Decided: May 8, 2013 after 219 days
- Product code: OMA (Amplitude-Integrated Electroencephalograph)
- Device class: 2
- Regulation: 21 CFR 882.1400
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K801604 (1980). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093949: Olympic Brainz Monitor Model OBM70001, Natus Medical, Inc. (2010) Summary page 1.
- K092039: Identevent, Version 1.0G, Optima Neuroscience, Inc. (2009) Summary page 1.
- K011397: Persyst Reveal, Persyst Development Corp. (2001) Summary page 1.

## Recalls of this device
- May 7, 2025 · Class II · Z-1925-2025: 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: 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 affec

## Indications for use
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.

Source page: https://510kreport.com/device/K123079
Methodology: https://510kreport.com/methodology