510(k) · Cleared
Recalled · Class II · 2019ElectroTek
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mobilemedtek · GWQ Full-Montage Standard Electroencephalograph
Cleared on Jun 5, 2017 as substantially equivalent to K143233 (Mitsar Co., Ltd., 2015) and 2 other predicates after a 111-day review. Its family tree reaches back 5 generations to 2000. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Jun 5, 2017
- Review
- 111 days
- Class
- Class II
- Product code
- GWQ
- Recalls
- 2
- Predicates
- 3
Its longest line of descent runs back 5 generations to K001564 (2000). 17 ancestors in all, the oldest K946094 (1995). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK001564 Scan LT40 (40 Channels)Neuro Scan Labs · 2000
- 4 generations backK023536 NuampsNeuroscan · 2003
- 3 generations backK060803 G.UsbampG.Tec Medical Engineering GmbH · 2006
- 2 generations backK090957 Blackrock Neuroport Biopotential Signal Processing SystemI2s Micro Implantable Systems, LLC · 2009 · Recalled
- 1 generation backK103140 Nicolet Wireless EegCarefusion 209, Inc. · 2011 · Recalled
- This deviceK170441 ElectroTekMobilemedtek · 2017
- Descendant · cites it directly · 0 of its ownK212788 Seer HomeSeer Medical Pty, Ltd. · 2022 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K212788Seer HomeSeer Medical Pty, Ltd. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K001564 | Scan LT40 (40 Channels) | Neuro Scan Labs | 2000 | — |
| −4 | K023536 | Nuamps | Neuroscan | 2003 | — |
| −3 | K060803 | G.Usbamp | G.Tec Medical Engineering GmbH | 2006 | — |
| −2 | K090957 | Blackrock Neuroport Biopotential Signal Processing System | I2s Micro Implantable Systems, LLC | 2009 | 2 |
| −1 | K103140 | Nicolet Wireless Eeg | Carefusion 209, Inc. | 2011 | 1 |
| 0 (this device) | K170441 | ElectroTek | Mobilemedtek | 2017 | — |
| +1 | K212788 | Seer Home | Seer Medical Pty, Ltd. | 2022 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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? (3)
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 |
|---|---|---|---|
| * | K143233 | Mitsar-EEGSummary page 4…plifier, Physiological Signal, 21 CFR 882.1835, Class II Product Code(s) GWQ GWL Legally marketed device(s) to K143233 – Mistar EEG which equivalence is claimed K103140 – Nicolet Wireless EEG K011204 – Neruo… | 2015 |
| * | K103140 | Nicolet Wireless EegSummary page 4…Product Code(s) GWQ GWL Legally marketed device(s) to K143233 – Mistar EEG which equivalence is claimed K103140 – Nicolet Wireless EEG K011204 – Neruofox, Models EEG-1100A, EEG-9100A Reason for 510(k) submi… | 2011 |
| * | K011204 | Neurofax, Models Eeg-1100A, Eeg-9100ASummary page 4…GWL Legally marketed device(s) to K143233 – Mistar EEG which equivalence is claimed K103140 – Nicolet Wireless EEG K011204 – Neruofox, Models EEG-1100A, EEG-9100A Reason for 510(k) submission New medical device intended for US commercial market.… | 2001 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K212788 | Seer Home | 2022 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 11, 2019 | Class II | Z-0722-2020 | Component change control | Potential for one of the four temporal electrode cables used in with the ElectroTek EEG system having incorrect placement labels which could lead to incorrect placement of electrode for an EEG study. |
| Oct 11, 2019 | Class II | Z-0723-2020 | Component change control | Potential for one of the four temporal electrode cables used in with the ElectroTek EEG system having incorrect placement labels which could lead to incorrect placement of electrode for an EEG study. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 6 companies; a new generation was cleared every 3.1 years on median.
- 3 of the 17 ancestors have a recall of any class.
- Of its descendants, K212788 (Seer Medical Pty, Ltd., 2022) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K143233.
How does its category compare?
All GWQ devicesGWQ Full-Montage Standard Electroencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 electroencephalographic system ElectroTek is intended to acquire, display, and store the electrical activity of a patient's brain obtained by placing electrodes on the patient scalp.
The ElectroTek is intended to be used for such studies as electroencephelogram (EEG) and video EEG recording to aid in diagnosis. The ElectroTek does not draw any diagnostic conclusions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170441 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170441: ElectroTek.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170441
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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