510(k) · Cleared
Clearedeego amplifiers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eemagine Medical Imaging Solutions GmbH · GWL Amplifier, Physiological Signal
Cleared on Mar 30, 2018 as substantially equivalent to K060374 (Tms International BV, 2006) after a 241-day review. Its family tree reaches back 1 generation to 2006. 2 later devices descend from it.
- Decided
- Mar 30, 2018
- Review
- 241 days
- Class
- Class II
- Product code
- GWL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K060374 (2006). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK060374 Refa, Physiological AmplifierTms International BV · 2006
- This deviceK172312 eego amplifiersEemagine Medical Imaging Solutions GmbH · 2018
- Descendant · cites it directly · 0 of its ownK243746 Delphi AmplifierQuantalx Neroscience · 2025
- Descendant · cites it directly · 0 of its ownK201747 8-CH Electroencephalography AmplifierHipposcreen Neurotech Corp. · 2020
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K060374 | Refa, Physiological Amplifier | Tms International BV | 2006 | — |
| 0 (this device) | K172312 | eego amplifiers | Eemagine Medical Imaging Solutions GmbH | 2018 | — |
| +1 | K243746 | Delphi Amplifier | Quantalx Neroscience | 2025 | — |
| +1 | K201747 | 8-CH Electroencephalography Amplifier | Hipposcreen Neurotech Corp. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 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 |
|---|---|---|---|
| * | K060374 | Refa, Physiological AmplifierSummary page 4…GWQ, full-montage standard electroencephalograph OMC, reduced- montage standard electroencephalograph Predicate Device 510(k) Number: K060374 Trade Name: REFA, Physiological Amplifier Submitter Name: TMS International BV Classification Name: 21… | 2006 |
| † | K110223 | Waveguard (TM) Eeg Cap | 2011 |
What descends from it? (2)
2 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?
- Its one ancestor has no recall.
- Of its descendants, K243746 (Quantalx Neroscience, 2025) has gone furthest, with 0 descendants of its own.
How does its category compare?
All GWL devicesGWL Amplifier, Physiological Signal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 eego amplifier is intended to be used by or under the direction of a physician for acquisition of EEG signals and to transmit them digitally to a computer. The device is intended for use on humans. The device is intended for use in a clinical environment (e.g., hospital, physician’s office, etc). The device is not intended for use in life support systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172312 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172312: eego amplifiers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172312
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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