510(k) · Cleared
ClearedGalileo NT
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eb Neuro S.P.A. · OLT Non-Normalizing Quantitative Electroencephalograph Software
Cleared on Feb 13, 2015 as substantially equivalent to K991054 (Nicolet Biomedical, Inc., 1999) and 2 other predicates after a 198-day review. Its family tree reaches back 2 generations to 1988. 2 later devices descend from it.
- Decided
- Feb 13, 2015
- Review
- 198 days
- Class
- Class II
- Product code
- OLT
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K874685 (1988). 9 ancestors in all, the oldest K870450 (1987). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK874685 Trans-Scan 3-D Transcranial DopplerCarolina Medical Electronics · 1988
- 1 generation backK991054 Bravo Multi-Modality SystemNicolet Biomedical, Inc. · 1999 · Recalled
- This deviceK142064 Galileo NTEb Neuro S.P.A. · 2015
- Descendant · cites it directly · 0 of its ownK242832 NExT Station; NExT Station AdvancedEb Neuro S.P.A. · 2024
- Descendant · cites it directly · 0 of its ownK242305 BE Plus PRO, Neurotravel LIGHTEb Neuro S.P.A. · 2024
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 |
|---|---|---|---|---|---|
| −2 | K874685 | Trans-Scan 3-D Transcranial Doppler | Carolina Medical Electronics | 1988 | — |
| −1 | K991054 | Bravo Multi-Modality System | Nicolet Biomedical, Inc. | 1999 | 4 |
| 0 (this device) | K142064 | Galileo NT | Eb Neuro S.P.A. | 2015 | — |
| +1 | K242832 | NExT Station; NExT Station Advanced | Eb Neuro S.P.A. | 2024 | — |
| +1 | K242305 | BE Plus PRO, Neurotravel LIGHT | Eb Neuro S.P.A. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 2 | 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 OLT? 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 OLT device
- #1 K253767 UB ERP Systemscore 14.9 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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 |
|---|---|---|---|
| * | K991054 | Bravo Multi-Modality SystemSummary page 5…Predicate Device(s) Device Owner 510(k) BRAVO Multimodality System Nicolet Biomedical, Inc K991054 Nemus 1 System EBNeuro SpA K073415 Twin Plus Software Astromed-Me… | 1999 |
| * | K073415 | Nemus System; Nemus PC PeripheralSummary page 5…510(k) BRAVO Multimodality System Nicolet Biomedical, Inc K991054 Nemus 1 System EBNeuro SpA K073415 Twin Plus Software Astromed-Med, Inc. K012976 807.92(a)(4)… | 2008 |
| * | K012976 | Twin PlusSummary page 5…Biomedical, Inc K991054 Nemus 1 System EBNeuro SpA K073415 Twin Plus Software Astromed-Med, Inc. K012976 807.92(a)(4) Device Description Galileo NT Line is a software package running… | 2002 |
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?
- The line of descent spans 27 years and passes through 3 companies; a new generation was cleared every 15.3 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K242832 (Eb Neuro S.P.A., 2024) has gone furthest, with 0 descendants of its own.
- 8 other devices also cite its predicate K991054.
How does its category compare?
All OLT devicesOLT Non-Normalizing Quantitative Electroencephalograph Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · OLT
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OLT
266in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OLT
No recall names OLT since 2007.
Adverse event reports per year · OLT
3in 2025
MAUDE reports naming product code OLT, 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 | 2 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 5 | 266 | 0 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 7 |
| 2019 | 2 | — | 0 | 2 |
| 2020 | 1 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 6 |
| 2022 | 2 | — | 0 | 4 |
| 2023 | 0 | — | 0 | 5 |
| 2024 | 1 | — | 0 | 4 |
| 2025 | 2 | — | 0 | 3 |
| 2026 | 3 | 217 | 0 | — |
What is it indicated for?
The GALILEO NT Line software is intended to record and display EEG, PSG, EMG and EP data acquired from the patient body through EBNeuro proprietary, FDA cleared, Acquisition Platform.(BE Plus LTM K121986, BE micro K093728, Nemus 2 system K133517.)
The device is intended to be used in the clinical and hospital environment (including the hospital room, emergency room, intensive care unit, neuro-intensive care unit, critical care unit) to aid the diagnosis and monitoring of potential disorders of the central and peripheral nervous system and muscles
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K142064 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142064: Galileo NT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142064
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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