510(k) · Cleared
ClearedNemus 2 System
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 Feb 26, 2014 as substantially equivalent to K073415 (Eb Neuro S.P.A., 2008) and 1 other predicate after a 103-day review. Its family tree reaches back 4 generations to 2001. 1 later device descends from it.
- Decided
- Feb 26, 2014
- Review
- 103 days
- Class
- Class II
- Product code
- GWL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K003154 (2001). 7 ancestors in all, the oldest K922488 (1993). 1 later device descends from it, 1 citing it directly.
- 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 deviceK133517 Nemus 2 SystemEb Neuro S.P.A. · 2014
- Descendant · cites it directly · 0 of its ownK242832 NExT Station; NExT Station AdvancedEb Neuro S.P.A. · 2024
Most influential descendants
Showing 1 of 1 · See all- K242832NExT Station; NExT Station AdvancedEb Neuro S.P.A. · 2024 · cites it directly0descendants
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) | K133517 | Nemus 2 System | Eb Neuro S.P.A. | 2014 | — |
| +1 | 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 |
|---|---|---|
| 1993 | 1 | 0 |
| 1998 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 |
|---|---|---|---|
| * | K073415 | Nemus System; Nemus PC PeripheralSummary page 1…Predicate Device(s) Device owner 510(k) Nemus 1 EB Neuro K073415 BE Plus [TM EB Neuro K(121996 ER Neuro, SpA Nemus 2 System… | 2008 |
| * | K121996 | BE Plus LTM Amplifier Gwi AmplifierSummary page 4…EDNeuro Sp.A. ERNeuro S.p.A. EBNeuro Sp.A. 5 10(k) number TRA K073415 K121996 Device class Class 11 Class 11 Class 11 Product code O… | 2012 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K242832 | NExT Station; NExT Station Advanced | 2024 | 0 |
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 13 years and passes through 1 company; a new generation was cleared every 3.4 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K242832 (Eb Neuro S.P.A., 2024) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K073415.
How does its category compare?
All GWL devicesGWL Amplifier, Physiological Signal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 Nemus 2 System is intended to acquire the bioclectric signals produced by the patient's central and peripheral nervous system and muscles. The acquired signals are transmitted to a PC during recording of neurophysiology examinations. The Nernus 2 System consists of a physiological signal amplifier, an evoked response auditory stimulator, an evoked response electrical stimulator, and an evoked response photic stimulator. The user needs to assure compatibility or the Nemus 2 System to the other components of the user's own System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133517 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133517: Nemus 2 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133517
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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