510(k) · Cleared
ClearedBE Plus PRO, Neurotravel LIGHT
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eb Neuro S.P.A. · GWL Amplifier, Physiological Signal
Cleared on Sep 4, 2024 as substantially equivalent to K121996 (Eb Neuro S.P.A., 2012) and 1 other predicate after a 30-day review. Its family tree reaches back 4 generations to 2001.
- Decided
- Sep 4, 2024
- Review
- 30 days
- Class
- Class II
- Product code
- GWL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K003154 (2001). 14 ancestors in all, the oldest K870450 (1987). No later device cites it as a predicate yet.
- Root · 4 generations backK003154 Mizar, Basis BE, Sandman DigitalEb Neuro S.P.A. · 2001
- 3 generations backK041198 NIC36 AmplifierEb Neuro S.P.A. · 2004
- 2 generations backK053606 BE Plus / Aura-LTM64 AmplifierEb Neuro S.P.A. · 2006
- 1 generation backK121996 BE Plus LTM Amplifier Gwi AmplifierEb Neuro S.P.A. · 2012
- This deviceK242305 BE Plus PRO, Neurotravel LIGHTEb Neuro S.P.A. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K003154 | Mizar, Basis BE, Sandman Digital | Eb Neuro S.P.A. | 2001 | — |
| −3 | K041198 | NIC36 Amplifier | Eb Neuro S.P.A. | 2004 | — |
| −2 | K053606 | BE Plus / Aura-LTM64 Amplifier | Eb Neuro S.P.A. | 2006 | — |
| −1 | K121996 | BE Plus LTM Amplifier Gwi Amplifier | Eb Neuro S.P.A. | 2012 | — |
| 0 (this device) | 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 |
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2008 | 1 | 0 |
| 2015 | 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 GWL? 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 GWL device
- #1 K232210 X-trodes System Mscore 10.4 · 13 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K121996 | BE Plus LTM Amplifier Gwi AmplifierSummary page 5…ical Signal Amplifier Regulation Number 882 1835 | Product Code(s) GWL, GWQ, OLT, OLV Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K121996 BE Plus LTM GWL K142064 | Galieo NT Software oLT EB Neuro S.p.A., Special 510(k) EEG Family Devices Page 1 of 10 === Page 6 ==… | 2012 |
| * | K142064 | Galileo NTSummary page 5…egulation Number 882 1835 | Product Code(s) GWL, GWQ, OLT, OLV Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K121996 BE Plus LTM GWL K142064 | Galieo NT Software oLT EB Neuro S.p.A., Special 510(k) EEG Family Devices Page 1 of 10 Device Description Sum… | 2015 |
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?
- The line of descent spans 23 years and passes through 1 company; a new generation was cleared every 6.5 years on median.
- 1 of the 14 ancestors has a recall of any class.
- 1 other device also cites its predicate K121996.
How does its category compare?
All GWL devicesGWL Amplifier, Physiological Signal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · GWL
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GWL
133in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GWL
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GWL
1in 2018
MAUDE reports naming product code GWL, 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 | 0 | — | 0 | 2 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 1 | — | 1 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 0 | — | 1 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 2 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 4 | 133 | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
BE Plus PRO and Neurotravel LIGHT are intended to be used for Electroencephalography (EEG) and Polysomnography (PSG) exams, in combination with the Galileo NT Line software, for human beings to assist the user in diagnosis and monitoring of 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/K242305 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242305: BE Plus PRO, Neurotravel LIGHT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242305
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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