510(k) · Cleared
ClearedBE Plus / Aura-LTM64 Amplifier
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 Jan 24, 2006 as substantially equivalent to K003154 (Eb Neuro S.P.A., 2001) and 1 other predicate after a 28-day review. Its family tree reaches back 2 generations to 2001. 9 later devices descend from it.
- Decided
- Jan 24, 2006
- Review
- 28 days
- Class
- Class II
- Product code
- GWL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K003154 (2001). 9 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK003154 Mizar, Basis BE, Sandman DigitalEb Neuro S.P.A. · 2001
- 1 generation backK041198 NIC36 AmplifierEb Neuro S.P.A. · 2004
- This deviceK053606 BE Plus / Aura-LTM64 AmplifierEb Neuro S.P.A. · 2006
- Descendant · cites it directly · 3 of its ownK121996 BE Plus LTM Amplifier Gwi AmplifierEb Neuro S.P.A. · 2012
- Descendant · cites it directly · 3 of its ownK101691 Lifelines Photic StimulatorLifelines, Ltd. · 2010
- Descendant · 2 generations on · 1 of its ownK133517 Nemus 2 SystemEb Neuro S.P.A. · 2014
- Descendant · 2 generations on · 0 of its ownK251366 EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit…Nihon Kohden Corporation · 2025
- Descendant · 3 generations on · 0 of its ownK242832 NExT Station; NExT Station AdvancedEb Neuro S.P.A. · 2024
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K121996BE Plus LTM Amplifier Gwi AmplifierEb Neuro S.P.A. · 2012 · cites it directly3descendants
- K101691Lifelines Photic StimulatorLifelines, Ltd. · 2010 · cites it directly3descendants
- K133517Nemus 2 SystemEb Neuro S.P.A. · 2014 · 2 generations on1descendant
- K251366EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A); LS-940A…Nihon Kohden Corporation · 2025 · 2 generations on0descendants
- K242832NExT Station; NExT Station AdvancedEb Neuro S.P.A. · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K003154 | Mizar, Basis BE, Sandman Digital | Eb Neuro S.P.A. | 2001 | — |
| −1 | K041198 | NIC36 Amplifier | Eb Neuro S.P.A. | 2004 | — |
| 0 (this device) | 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 | — |
| +1 | K101691 | Lifelines Photic Stimulator | Lifelines, Ltd. | 2010 | — |
| +2 | K133517 | Nemus 2 System | Eb Neuro S.P.A. | 2014 | — |
| +2 | K251366 | EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A)… | Nihon Kohden Corporation | 2025 | — |
| +3 | K242832 | NExT Station; NExT Station Advanced | Eb Neuro S.P.A. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K003154 | Mizar, Basis BE, Sandman DigitalSummary page 1…cation Number: 84GWL 807.92(a)(3) Predicate Device(s) EB Neuro, S.p.A. MIZAR Amplifier K003154 EB Neuro, S.p.A. NIC36 Amplifier K041198 Additional Substantial Equivalence Information is… | 2001 |
| * | K041198 | NIC36 AmplifierSummary page 1…redicate Device(s) EB Neuro, S.p.A. MIZAR Amplifier K003154 EB Neuro, S.p.A. NIC36 Amplifier K041198 Additional Substantial Equivalence Information is provided in the following Substantial Equivalence Comparison Table.… | 2004 |
What descends from it? (9)
3 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 5 years and passes through 1 company; a new generation was cleared every 3.4 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K121996 (Eb Neuro S.P.A., 2012) has gone furthest, with 3 descendants of its own.
- 4 other devices also cite its predicate K003154.
How does its category compare?
All GWL devicesGWL Amplifier, Physiological Signal: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 BE Plus / AURA-LTM64 Amplifier is intended to be used by or under the direction
of a physician for acquisition of EEG, polygraphy and polysomnography signals and
transmission of these signals to a PC during recording of neurophysiology
examinations.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053606 · printed Nov 4, 2026
Cite this page
510(k) Report. “K053606: BE Plus / Aura-LTM64 Amplifier.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K053606
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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