510(k) · Cleared
ClearedWR19 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 17, 2018 as substantially equivalent to K131383 (Advanced Brain Monitoring, Inc., 2013) after a 218-day review. Its family tree reaches back 8 generations to 1987. 3 later devices descend from it.
- Decided
- Apr 17, 2018
- Review
- 218 days
- Class
- Class II
- Product code
- GWQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K873535 (1987). 21 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK873535 Nicolet Expert Sleep/Wake Analysis SystemNicolet Biomedical Instruments · 1987
- 7 generations backK955841 Sleep System for Clinics & ResearchCompumedics Ptd, Ltd. · 1997
- 6 generations backK072014 VitascoreVitascore B.V. · 2007
- 5 generations backK082968 Apneicare Connection Center/Internet AnalysisApneicare, LLC · 2009
- 4 generations backK112514 Apnea Risk Evaluation System (Ares)Advanced Brain Monitoring, Inc. · 2012
- 3 generations backK120447 X4Advanced Brain Monitoring, Inc. · 2012
- 2 generations backK130013 X4 SystemAdvanced Brain Monitoring, Inc. · 2013
- 1 generation backK131383 X10 Headset with X-Series Basic Software, X24 Headset with X-Series…Advanced Brain Monitoring, Inc. · 2013
- This deviceK172735 WR19 SystemZeto, Inc. · 2018
- Descendant · cites it directly · 1 of its ownK233403 Flexset SystemZeto, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK260455 New Wave SystemZeto, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK220056 iSyncWaveiMediSync, Inc. · 2022
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 |
|---|---|---|---|---|---|
| −8 | K873535 | Nicolet Expert Sleep/Wake Analysis System | Nicolet Biomedical Instruments | 1987 | — |
| −7 | K955841 | Sleep System for Clinics & Research | Compumedics Ptd, Ltd. | 1997 | — |
| −6 | K072014 | Vitascore | Vitascore B.V. | 2007 | — |
| −5 | K082968 | Apneicare Connection Center/Internet Analysis | Apneicare, LLC | 2009 | — |
| −4 | K112514 | Apnea Risk Evaluation System (Ares) | Advanced Brain Monitoring, Inc. | 2012 | — |
| −3 | K120447 | X4 | Advanced Brain Monitoring, Inc. | 2012 | — |
| −2 | K130013 | X4 System | Advanced Brain Monitoring, Inc. | 2013 | — |
| −1 | K131383 | X10 Headset with X-Series Basic Software, X24 Headset with X-Series Basic… | Advanced Brain Monitoring, Inc. | 2013 | — |
| 0 (this device) | K172735 | WR19 System | Zeto, Inc. | 2018 | — |
| +1 | K233403 | Flexset System | Zeto, Inc. | 2024 | — |
| +2 | K260455 | New Wave System | Zeto, Inc. | 2026 | — |
| +1 | K220056 | iSyncWave | iMediSync, Inc. | 2022 | — |
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 |
|---|---|---|
| 2022 | 1 | 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? (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 |
|---|---|---|---|
| * | K131383 | X10 Headset with X-Series Basic Software, X24 Headset with X-Series Basic SoftwareSummary page 4…tandard electroencephalograph Classification Name Electroencephalograph 21 CFR 882.1400 Product Codes GWQ, GXY Primary Predicate K131383 X10 Headset with X-series Basic Software, X24 Headset with X-series Basic Software Reference Predi… | 2013 |
| † | K171669 | g.Nautilus PRO | 2017 |
| † | K163163 | XLTEK EMU40EX EEG Headbox | 2016 |
What descends from it? (3)
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?
- The line of descent spans 31 years and passes through 6 companies; a new generation was cleared every 3.0 years on median.
- 1 of the 21 ancestors has a recall of any class.
- Of its descendants, K233403 (Zeto, Inc., 2024) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K131383.
How does its category compare?
All GWQ devicesGWQ Full-Montage Standard Electroencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 WR19 System is intended for prescription use in a health care facility or clinical research environment to acquire, transmit, display and store primarily EEG and optional auxiliary signals for adults and children, not including newborns.
The WR19 System requires operation by a healthcare professional familiar with EEG.
The WR19 System acquires, transmits, displays and stores electroencephalogram (EEG), and optionally electrocardiogram (ECG), accelerometer, photic sensor, external trigger signals and video.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172735 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172735: WR19 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172735
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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