510(k) · Cleared
ClearedRefa, Physiological Amplifier
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tms International BV · GWL Amplifier, Physiological Signal
Cleared on May 30, 2006 after a 106-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it.
- Decided
- May 30, 2006
- Review
- 106 days
- Class
- Class II
- Product code
- GWL
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK060374 Refa, Physiological AmplifierTms International BV · 2006
- Descendant · cites it directly · 2 of its ownK172312 eego amplifiersEemagine Medical Imaging Solutions GmbH · 2018
- Descendant · 2 generations on · 0 of its ownK243746 Delphi AmplifierQuantalx Neroscience · 2025
- Descendant · 2 generations on · 0 of its ownK201747 8-CH Electroencephalography AmplifierHipposcreen Neurotech Corp. · 2020
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K060374 | Refa, Physiological Amplifier | Tms International BV | 2006 | — |
| +1 | K172312 | eego amplifiers | Eemagine Medical Imaging Solutions GmbH | 2018 | — |
| +2 | K243746 | Delphi Amplifier | Quantalx Neroscience | 2025 | — |
| +2 | K201747 | 8-CH Electroencephalography Amplifier | Hipposcreen Neurotech Corp. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K172312 | eego amplifiers | 2018 | 2 |
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?
- Of its descendants, K172312 (Eemagine Medical Imaging Solutions GmbH, 2018) has gone furthest, with 2 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.
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 REFA Physiological Amplifier family is intended to be used by or under the direction of a physician for acquisition of EEG, polygraphy and polysomnography signals and transmission of the signals to a PC during recording of neuro-physical/ physiological research and exams.
Polygraphy and Polysomnography may besides EEG, include physiological information such as EMG, ECG, EOG, EGG, PH, Respiration, Temperature and Oxygen Saturation.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K060374 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060374: Refa, Physiological Amplifier.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060374
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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