510(k) · Cleared
ClearedNew Wave 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 Mar 13, 2026 as substantially equivalent to K233403 (Zeto, Inc., 2024) after a 30-day review. Its family tree reaches back 10 generations to 1987.
- Decided
- Mar 13, 2026
- Review
- 30 days
- Class
- Class II
- Product code
- GWQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K873535 (1987). 23 ancestors in all. No later device cites it as a predicate yet.
- Root · 10 generations backK873535 Nicolet Expert Sleep/Wake Analysis SystemNicolet Biomedical Instruments · 1987
- 6 generations between
- 3 generations backK131383 X10 Headset with X-Series Basic Software, X24 Headset with X-Series…Advanced Brain Monitoring, Inc. · 2013
- 2 generations backK172735 WR19 SystemZeto, Inc. · 2018
- 1 generation backK233403 Flexset SystemZeto, Inc. · 2024
- This deviceK260455 New Wave SystemZeto, Inc. · 2026
Show all 10 generations
- Root · 10 generations backK873535 Nicolet Expert Sleep/Wake Analysis SystemNicolet Biomedical Instruments · 1987
- 9 generations backK955841 Sleep System for Clinics & ResearchCompumedics Ptd, Ltd. · 1997
- 8 generations backK072014 VitascoreVitascore B.V. · 2007
- 7 generations backK082968 Apneicare Connection Center/Internet AnalysisApneicare, LLC · 2009
- 6 generations backK112514 Apnea Risk Evaluation System (Ares)Advanced Brain Monitoring, Inc. · 2012
- 5 generations backK120447 X4Advanced Brain Monitoring, Inc. · 2012
- 4 generations backK130013 X4 SystemAdvanced Brain Monitoring, Inc. · 2013
- 3 generations backK131383 X10 Headset with X-Series Basic Software, X24 Headset with X-Series…Advanced Brain Monitoring, Inc. · 2013
- 2 generations backK172735 WR19 SystemZeto, Inc. · 2018
- 1 generation backK233403 Flexset SystemZeto, Inc. · 2024
- This deviceK260455 New Wave SystemZeto, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K873535 | Nicolet Expert Sleep/Wake Analysis System | Nicolet Biomedical Instruments | 1987 | — |
| −9 | K955841 | Sleep System for Clinics & Research | Compumedics Ptd, Ltd. | 1997 | — |
| −8 | K072014 | Vitascore | Vitascore B.V. | 2007 | — |
| −7 | K082968 | Apneicare Connection Center/Internet Analysis | Apneicare, LLC | 2009 | — |
| −6 | K112514 | Apnea Risk Evaluation System (Ares) | Advanced Brain Monitoring, Inc. | 2012 | — |
| −5 | K120447 | X4 | Advanced Brain Monitoring, Inc. | 2012 | — |
| −4 | K130013 | X4 System | Advanced Brain Monitoring, Inc. | 2013 | — |
| −3 | K131383 | X10 Headset with X-Series Basic Software, X24 Headset with X-Series Basic… | Advanced Brain Monitoring, Inc. | 2013 | — |
| −2 | K172735 | WR19 System | Zeto, Inc. | 2018 | — |
| −1 | K233403 | Flexset System | Zeto, Inc. | 2024 | — |
| 0 (this device) | 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 |
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 K261604 Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx…score 13.0 · 6 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 |
|---|---|---|---|
| * | K233403 | Flexset SystemSummary page 5…dicate Device Information Element Information Predicate Device Name Flexset System Predicate 510(k) Number K233403 New Wave… | 2024 |
What descends from it?
No later submission names this one as a predicate yet.
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 39 years and passes through 6 companies; a new generation was cleared every 3.0 years on median.
- 1 of the 23 ancestors has a recall of any class.
How does its category compare?
All GWQ devicesGWQ Full-Montage Standard Electroencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 New Wave system is intended for prescription use in an outpatient healthcare facility or home use to acquire, transmit, display and store EEG and auxiliary signals for adults and children, not including newborns. The New Wave 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. The system is only intended to be used for short-term recordings up to 2.5 hours.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K260455 · printed Nov 4, 2026
Cite this page
510(k) Report. “K260455: New Wave System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K260455
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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