510(k) · Cleared
ClearedNExT Station; NExT Station Advanced
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 Dec 12, 2024 as substantially equivalent to K133517 (Eb Neuro S.P.A., 2014) and 1 other predicate after an 84-day review. Its family tree reaches back 5 generations to 2001.
- Decided
- Dec 12, 2024
- Review
- 84 days
- Class
- Class II
- Product code
- GWL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K003154 (2001). 15 ancestors in all, the oldest K870450 (1987). No later device cites it as a predicate yet.
- Root · 5 generations backK003154 Mizar, Basis BE, Sandman DigitalEb Neuro S.P.A. · 2001
- 4 generations backK041198 NIC36 AmplifierEb Neuro S.P.A. · 2004
- 3 generations backK053606 BE Plus / Aura-LTM64 AmplifierEb Neuro S.P.A. · 2006
- 2 generations backK121996 BE Plus LTM Amplifier Gwi AmplifierEb Neuro S.P.A. · 2012
- 1 generation backK133517 Nemus 2 SystemEb Neuro S.P.A. · 2014
- This deviceK242832 NExT Station; NExT Station AdvancedEb Neuro S.P.A. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K003154 | Mizar, Basis BE, Sandman Digital | Eb Neuro S.P.A. | 2001 | — |
| −4 | K041198 | NIC36 Amplifier | Eb Neuro S.P.A. | 2004 | — |
| −3 | K053606 | BE Plus / Aura-LTM64 Amplifier | Eb Neuro S.P.A. | 2006 | — |
| −2 | K121996 | BE Plus LTM Amplifier Gwi Amplifier | Eb Neuro S.P.A. | 2012 | — |
| −1 | K133517 | Nemus 2 System | Eb Neuro S.P.A. | 2014 | — |
| 0 (this device) | K242832 | NExT Station; NExT Station Advanced | 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 |
|---|---|---|---|
| * | K133517 | Nemus 2 SystemSummary page 5…OLT, IKN – EP and EMG GWE, GWF, GWJ – Auditory, Photic and Electrical stimulators Device Class: Class II Predicate Device: K133517, Nemus 2 System (Hardware, amplifier) (GWL) K142064, Galileo NT Software (OLT)… | 2014 |
| * | K142064 | Galileo NTSummary page 5…otic and Electrical stimulators Device Class: Class II Predicate Device: K133517, Nemus 2 System (Hardware, amplifier) (GWL) K142064, Galileo NT Software (OLT) EB Neuro S.p.A. 21 CFR 882.1835 EB Neuro S.p.A.,… | 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 3.4 years on median.
- 1 of the 15 ancestors has a recall of any class.
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?
The NExT Station and NExT Station Advanced are physiological signal amplifiers intended to be used during Electromyography (EMG) and Evoked Potential (EP) exams to acquire bioelectric signals produced by the patient’s central and peripheral nervous system and muscles. The devices include Galileo NT Line software to record and display acquired data to aid the diagnosis and monitoring of potential disorders of the central and peripheral nervous system and muscles.
The devices include an electrical stimulator, an auditory stimulator, and a photic stimulator as accessories that may optionally be used in evoked response analysis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K242832 · printed Nov 5, 2026
Cite this page
510(k) Report. “K242832: NExT Station; NExT Station Advanced.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K242832
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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