510(k) · Cleared
ClearedMitsar-EEG
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mitsar Co., Ltd. · GWQ Full-Montage Standard Electroencephalograph
Cleared on Aug 13, 2015 as substantially equivalent to K061908 (Viasys Neuro Care, 2006) and 1 other predicate after a 276-day review. Its family tree reaches back 2 generations to 1997. 11 later devices descend from it.
- Decided
- Aug 13, 2015
- Review
- 276 days
- Class
- Class II
- Product code
- GWQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K964280 (1997). 4 ancestors in all, the oldest K946094 (1995). 11 later devices descend from it, 5 citing it directly.
- Root · 2 generations backK964280 DG NervusMedelec, Ltd. · 1997 · Recalled
- 1 generation backK061908 Nicoletone System V32 AmplifierViasys Neuro Care · 2006
- This deviceK143233 Mitsar-EEGMitsar Co., Ltd. · 2015
- Descendant · cites it directly · 6 of its ownK171781 eVox SystemEvoke Neuroscience, Inc. · 2017
- Descendant · 2 generations on · 3 of its ownK192753 NeuralScan SystemMedeia, Inc. · 2020
- Descendant · 3 generations on · 1 of its ownK221963 Cumulus Functional Neurophysiology PlatformCumulus Neuroscience Limited · 2023
- Descendant · cites it directly · 1 of its ownK170441 ElectroTekMobilemedtek · 2017 · Recalled
- Descendant · 3 generations on · 0 of its ownK253767 UB ERP SystemUniversal Brain · 2026
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K171781eVox SystemEvoke Neuroscience, Inc. · 2017 · cites it directly6descendants
- K192753NeuralScan SystemMedeia, Inc. · 2020 · 2 generations on3descendants
- K221963Cumulus Functional Neurophysiology PlatformCumulus Neuroscience Limited · 2023 · 3 generations on1descendant
- K170441ElectroTekMobilemedtek · 2017 · cites it directly1descendant
- K253767UB ERP SystemUniversal Brain · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K964280 | DG Nervus | Medelec, Ltd. | 1997 | 1 |
| −1 | K061908 | Nicoletone System V32 Amplifier | Viasys Neuro Care | 2006 | — |
| 0 (this device) | K143233 | Mitsar-EEG | Mitsar Co., Ltd. | 2015 | — |
| +1 | K171781 | eVox System | Evoke Neuroscience, Inc. | 2017 | — |
| +2 | K192753 | NeuralScan System | Medeia, Inc. | 2020 | — |
| +3 | K221963 | Cumulus Functional Neurophysiology Platform | Cumulus Neuroscience Limited | 2023 | — |
| +1 | K170441 | ElectroTek | Mobilemedtek | 2017 | 2 |
| +3 | K253767 | UB ERP System | Universal Brain | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 2 | 0 |
| 2020 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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 GWQ? 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 GWQ device
- #1 K260455 New Wave Systemscore 13.7 · 10 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 |
|---|---|---|---|
| * | K061908 | Nicoletone System V32 AmplifierSummary page 4…Neurology 5.3 Predicate Devices 510(K) Classification Trade or Proprietary Manufacturer Number Product Code or Model Name K061908 GWQ NicoletOne System VIASYS NeuroCare, Inc. V32 Amp… | 2006 |
| * | K946094 | Cadwell Easy Ambulatory EegSummary page 5…sar Co. Ltd. K143233/S002 Interactive Review Madison, WI 53711 K946094 GWQ Cadwell Easy II EEG Cadwell Laboratories Inc.… | 1995 |
What descends from it? (11)
See all 115 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 18 years and passes through 3 companies; a new generation was cleared every 9.8 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K171781 (Evoke Neuroscience, Inc., 2017) has gone furthest, with 6 descendants of its own.
- 2 other devices also cite its predicate K061908.
How does its category compare?
All GWQ devicesGWQ Full-Montage Standard Electroencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · GWQ
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · GWQ
137in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GWQ
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GWQ
13in 2025
MAUDE reports naming product code GWQ, 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 | — | 5 | 11 |
| 2008 | 2 | — | 2 | 8 |
| 2009 | 0 | — | 1 | 7 |
| 2010 | 3 | 73 | 1 | 12 |
| 2011 | 4 | 220 | 0 | 6 |
| 2012 | 4 | 208 | 0 | 9 |
| 2013 | 2 | — | 0 | 4 |
| 2014 | 2 | — | 0 | 7 |
| 2015 | 3 | 276 | 2 | 13 |
| 2016 | 3 | 50 | 0 | 28 |
| 2017 | 5 | 181 | 0 | 17 |
| 2018 | 8 | 150 | 0 | 15 |
| 2019 | 0 | — | 2 | 16 |
| 2020 | 6 | 216 | 1 | 30 |
| 2021 | 0 | — | 0 | 20 |
| 2022 | 3 | 216 | 0 | 16 |
| 2023 | 6 | 137 | 0 | 20 |
| 2024 | 1 | — | 0 | 17 |
| 2025 | 0 | — | 0 | 13 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The Mitsar-EEG is intended to acquire, display and store the electrical activity of a patient's brain obtained by placing two or more electrodes on the head to aid in diagnosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143233 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143233: Mitsar-EEG.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143233
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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