510(k) · Cleared
ClearedNeo
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eemagine Medical Imaging Solutions GmbH · OMA Amplitude-Integrated Electroencephalograph
Cleared on Jan 30, 2020 as substantially equivalent to K093949 (Natus Medical, Inc., 2010) after a 112-day review. Its family tree reaches back 1 generation to 2010.
- Decided
- Jan 30, 2020
- Review
- 112 days
- Class
- Class II
- Product code
- OMA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K093949 (2010). No later device cites it as a predicate yet.
- Root · 1 generation backK093949 Olympic Brainz Monitor Model OBM70001Natus Medical, Inc. · 2010
- This deviceK192889 NeoEemagine Medical Imaging Solutions GmbH · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K093949 | Olympic Brainz Monitor Model OBM70001 | Natus Medical, Inc. | 2010 | — |
| 0 (this device) | K192889 | Neo | Eemagine Medical Imaging Solutions GmbH | 2020 | — |
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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
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 |
|---|---|---|---|
| * | K093949 | Olympic Brainz Monitor Model OBM70001Summary page 5…amplifier • Mounting plate • nëo User Manual Substantial equivalence: The nëo™ system is substantially equivalent to the Olympic Brainz Monitor (K093949, June 16, 2010). Summary of technological characteristics compared to predicate devices: Device Feature… | 2010 |
| † | K152301 | Background Pattern Classification [BPc (TM)] | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no 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. 2020, 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 nëo monitor is an 8-channel electroencephalograph (EEG) acquisition software. The device is intended to record and display EEG and aEEG signals for monitoring the brain status of neonatal patients (defined as from birth to 28 days post-delivery, and corresponding to a postconceptual age of 24 to 46 weeks). The device is to be used in a hospital environment by qualified clinical practitioners. The device does not provide any diagnostic conclusion about the patient's condition to the user.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192889 · printed Nov 4, 2026
Cite this page
510(k) Report. “K192889: Neo.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K192889
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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