510(k) · Cleared
ClearedNIC36 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 Jun 1, 2004 as substantially equivalent to K003154 (Eb Neuro S.P.A., 2001) after a 25-day review. Its family tree reaches back 1 generation to 2001. 10 later devices descend from it.
- Decided
- Jun 1, 2004
- Review
- 25 days
- Class
- Class II
- Product code
- GWL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K003154 (2001). 10 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK003154 Mizar, Basis BE, Sandman DigitalEb Neuro S.P.A. · 2001
- This deviceK041198 NIC36 AmplifierEb Neuro S.P.A. · 2004
- Descendant · cites it directly · 9 of its ownK053606 BE Plus / Aura-LTM64 AmplifierEb Neuro S.P.A. · 2006
- Descendant · 2 generations on · 3 of its ownK121996 BE Plus LTM Amplifier Gwi AmplifierEb Neuro S.P.A. · 2012
- Descendant · 2 generations on · 3 of its ownK101691 Lifelines Photic StimulatorLifelines, Ltd. · 2010
- Descendant · 3 generations on · 1 of its ownK133517 Nemus 2 SystemEb Neuro S.P.A. · 2014
- Descendant · 3 generations on · 0 of its ownK251366 EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit…Nihon Kohden Corporation · 2025
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K053606BE Plus / Aura-LTM64 AmplifierEb Neuro S.P.A. · 2006 · cites it directly9descendants
- K121996BE Plus LTM Amplifier Gwi AmplifierEb Neuro S.P.A. · 2012 · 2 generations on3descendants
- K101691Lifelines Photic StimulatorLifelines, Ltd. · 2010 · 2 generations on3descendants
- K133517Nemus 2 SystemEb Neuro S.P.A. · 2014 · 3 generations on1descendant
- K251366EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A); LS-940A…Nihon Kohden Corporation · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K003154 | Mizar, Basis BE, Sandman Digital | Eb Neuro S.P.A. | 2001 | — |
| 0 (this device) | K041198 | NIC36 Amplifier | Eb Neuro S.P.A. | 2004 | — |
| +1 | 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 | — |
| +2 | K101691 | Lifelines Photic Stimulator | Lifelines, Ltd. | 2010 | — |
| +3 | K133517 | Nemus 2 System | Eb Neuro S.P.A. | 2014 | — |
| +3 | K251366 | EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A)… | Nihon Kohden Corporation | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 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? (1)
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…er: 84GWL 807.92(a)(3) Predicate Device(s) EB Neuro, S.p.A. Mizar Amplifier K003154 Additional Substantial Equivalence Information is provided in the following Technological Characteristics Table.… | 2001 |
What descends from it? (10)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K053606 | BE Plus / Aura-LTM64 Amplifier | 2006 | 9 |
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?
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 Nic36 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/K041198 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041198: NIC36 Amplifier.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041198
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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