510(k) · Cleared
ClearedFlexset System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zeto, Inc. · GWQ Full-Montage Standard Electroencephalograph
Cleared on Apr 30, 2024 as substantially equivalent to K172735 (Zeto, Inc., 2018) and 1 other predicate after a 209-day review. Its family tree reaches back 9 generations to 1987. 1 later device descends from it.
- Decided
- Apr 30, 2024
- Review
- 209 days
- Class
- Class II
- Product code
- GWQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K873535 (1987). 22 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 9 generations backK873535 Nicolet Expert Sleep/Wake Analysis SystemNicolet Biomedical Instruments · 1987
- 5 generations between
- 3 generations backK130013 X4 SystemAdvanced Brain Monitoring, Inc. · 2013
- 2 generations backK131383 X10 Headset with X-Series Basic Software, X24 Headset with X-Series…Advanced Brain Monitoring, Inc. · 2013
- 1 generation backK172735 WR19 SystemZeto, Inc. · 2018
- This deviceK233403 Flexset SystemZeto, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK260455 New Wave SystemZeto, Inc. · 2026
Show all 9 generations
- Root · 9 generations backK873535 Nicolet Expert Sleep/Wake Analysis SystemNicolet Biomedical Instruments · 1987
- 8 generations backK955841 Sleep System for Clinics & ResearchCompumedics Ptd, Ltd. · 1997
- 7 generations backK072014 VitascoreVitascore B.V. · 2007
- 6 generations backK082968 Apneicare Connection Center/Internet AnalysisApneicare, LLC · 2009
- 5 generations backK112514 Apnea Risk Evaluation System (Ares)Advanced Brain Monitoring, Inc. · 2012
- 4 generations backK120447 X4Advanced Brain Monitoring, Inc. · 2012
- 3 generations backK130013 X4 SystemAdvanced Brain Monitoring, Inc. · 2013
- 2 generations backK131383 X10 Headset with X-Series Basic Software, X24 Headset with X-Series…Advanced Brain Monitoring, Inc. · 2013
- 1 generation backK172735 WR19 SystemZeto, Inc. · 2018
- This deviceK233403 Flexset SystemZeto, Inc. · 2024
Most influential descendants
Showing 1 of 1 · See all- K260455New Wave SystemZeto, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K873535 | Nicolet Expert Sleep/Wake Analysis System | Nicolet Biomedical Instruments | 1987 | — |
| −8 | K955841 | Sleep System for Clinics & Research | Compumedics Ptd, Ltd. | 1997 | — |
| −7 | K072014 | Vitascore | Vitascore B.V. | 2007 | — |
| −6 | K082968 | Apneicare Connection Center/Internet Analysis | Apneicare, LLC | 2009 | — |
| −5 | K112514 | Apnea Risk Evaluation System (Ares) | Advanced Brain Monitoring, Inc. | 2012 | — |
| −4 | K120447 | X4 | Advanced Brain Monitoring, Inc. | 2012 | — |
| −3 | K130013 | X4 System | Advanced Brain Monitoring, Inc. | 2013 | — |
| −2 | K131383 | X10 Headset with X-Series Basic Software, X24 Headset with X-Series Basic… | Advanced Brain Monitoring, Inc. | 2013 | — |
| −1 | K172735 | WR19 System | Zeto, Inc. | 2018 | — |
| 0 (this device) | K233403 | Flexset System | Zeto, Inc. | 2024 | — |
| +1 | K260455 | New Wave System | Zeto, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K172735 | WR19 SystemSummary page 5…alograph Classification Regulation: 21 CFR 882.1400, Class II Panel: Neurology Primary Product Code: GWQ Secondary Product Code: GXY Predicate Devices: Zeto WR19 System (K172735, primary), X-Series System (K131383, secondary) Submission number: K233403 Date: 2024-04-29 1. Indications for use The Flexset… | 2018 |
| * | K131383 | X10 Headset with X-Series Basic Software, X24 Headset with X-Series Basic SoftwareSummary page 5…21 CFR 882.1400, Class II Panel: Neurology Primary Product Code: GWQ Secondary Product Code: GXY Predicate Devices: Zeto WR19 System (K172735, primary), X-Series System (K131383, secondary) Submission number: K233403 Date: 2024-04-29 1. Indications for use The Flexset system is intended for prescription… | 2013 |
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 |
|---|---|---|---|
| K260455 | New Wave System | 2026 | 0 |
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 37 years and passes through 6 companies; a new generation was cleared every 3.0 years on median.
- 1 of the 22 ancestors has a recall of any class.
- Of its descendants, K260455 (Zeto, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K172735.
How does its category compare?
All GWQ devicesGWQ Full-Montage Standard Electroencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 Flexset system is intended for prescription use in a healthcare facility, home, and specific
transport environments to acquire, transmit, display and store EEG and auxiliary signals for adults
and children, not including newborns. The Flexset system acquires, transmits, displays and stores
electroencephalogram (EEG), and optionally electrocardiogram (ECG), electrooculogram (EOG),
electromyogram (EMG), orientation sensor data, photic sensor data, external trigger signals and
video.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K233403 · printed Nov 4, 2026
Cite this page
510(k) Report. “K233403: Flexset System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K233403
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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