510(k) · Cleared
ClearedX10 Headset with X-Series Basic Software, X24 Headset with X-Series Basic Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advanced Brain Monitoring, Inc. · GWQ Full-Montage Standard Electroencephalograph
Cleared on Nov 27, 2013 as substantially equivalent to K130013 (Advanced Brain Monitoring, Inc., 2013) after a 197-day review. Its family tree reaches back 7 generations to 1987. 14 later devices descend from it.
- Decided
- Nov 27, 2013
- Review
- 197 days
- Class
- Class II
- Product code
- GWQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K873535 (1987). 20 ancestors in all. 14 later devices descend from it, 5 citing it directly.
- Root · 7 generations backK873535 Nicolet Expert Sleep/Wake Analysis SystemNicolet Biomedical Instruments · 1987
- 6 generations backK955841 Sleep System for Clinics & ResearchCompumedics Ptd, Ltd. · 1997
- 5 generations backK072014 VitascoreVitascore B.V. · 2007
- 4 generations backK082968 Apneicare Connection Center/Internet AnalysisApneicare, LLC · 2009
- 3 generations backK112514 Apnea Risk Evaluation System (Ares)Advanced Brain Monitoring, Inc. · 2012
- 2 generations backK120447 X4Advanced Brain Monitoring, Inc. · 2012
- 1 generation backK130013 X4 SystemAdvanced Brain Monitoring, Inc. · 2013
- This deviceK131383 X10 Headset with X-Series Basic Software, X24 Headset with X-Series…Advanced Brain Monitoring, Inc. · 2013
- Descendant · cites it directly · 7 of its ownK141316 Cognision Eeg/EP SystemNeuronetrix Solutions · 2015
- Descendant · 2 generations on · 6 of its ownK171781 eVox SystemEvoke Neuroscience, Inc. · 2017
- Descendant · 2 generations on · 3 of its ownK192753 NeuralScan SystemMedeia, Inc. · 2020
- Descendant · cites it directly · 3 of its ownK172735 WR19 SystemZeto, Inc. · 2018
- Descendant · cites it directly · 1 of its ownK233403 Flexset SystemZeto, Inc. · 2024
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K141316Cognision Eeg/EP SystemNeuronetrix Solutions · 2015 · cites it directly7descendants
- K171781eVox SystemEvoke Neuroscience, Inc. · 2017 · 2 generations on6descendants
- K192753NeuralScan SystemMedeia, Inc. · 2020 · 2 generations on3descendants
- K172735WR19 SystemZeto, Inc. · 2018 · cites it directly3descendants
- K233403Flexset SystemZeto, Inc. · 2024 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K873535 | Nicolet Expert Sleep/Wake Analysis System | Nicolet Biomedical Instruments | 1987 | — |
| −6 | K955841 | Sleep System for Clinics & Research | Compumedics Ptd, Ltd. | 1997 | — |
| −5 | K072014 | Vitascore | Vitascore B.V. | 2007 | — |
| −4 | K082968 | Apneicare Connection Center/Internet Analysis | Apneicare, LLC | 2009 | — |
| −3 | K112514 | Apnea Risk Evaluation System (Ares) | Advanced Brain Monitoring, Inc. | 2012 | — |
| −2 | K120447 | X4 | Advanced Brain Monitoring, Inc. | 2012 | — |
| −1 | K130013 | X4 System | Advanced Brain Monitoring, Inc. | 2013 | — |
| 0 (this device) | K131383 | X10 Headset with X-Series Basic Software, X24 Headset with X-Series Basic… | Advanced Brain Monitoring, Inc. | 2013 | — |
| +1 | K141316 | Cognision Eeg/EP System | Neuronetrix Solutions | 2015 | — |
| +2 | K171781 | eVox System | Evoke Neuroscience, Inc. | 2017 | — |
| +2 | K192753 | NeuralScan System | Medeia, Inc. | 2020 | — |
| +1 | K172735 | WR19 System | Zeto, Inc. | 2018 | — |
| +1 | K233403 | Flexset System | Zeto, Inc. | 2024 | — |
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 |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2026 | 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 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 |
|---|---|---|---|
| * | K130013 | X4 SystemSummary page 1…. DEVICE: TRADE NAME: X-Series System COMMON/USUAL NAME: X10 /X24 CLASSIFICATION NAMES: 882.1400 Electroencephalograph PRODUCT CODE: GWQ, OCC PREDICATE DEVICE(S): K130013 X4 System 18 Advanced Brain Monitor… | 2013 |
What descends from it? (14)
See all 145 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 26 years and passes through 5 companies; a new generation was cleared every 1.2 years on median.
- 1 of the 20 ancestors has a recall of any class.
- Of its descendants, K141316 (Neuronetrix Solutions, 2015) has gone furthest, with 7 descendants of its own.
- 1 other device also cites its predicate K130013.
How does its category compare?
All GWQ devicesGWQ Full-Montage Standard Electroencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 X-Series System is intended for prescription use in the home, healthcare facility, or clinical research environment to acquire, transmit, display and store physiological signals from patients ages 6 and older. The X-Series system requires operation by a trained technician. The X-Series System acquires, transmits, displays and stores electroencephalogram (EEG), electrooculogramn (EOG), electrocardiogram (ECG), and/or electromyogram (EMG), and accelerometer signals. The X-Series System only acquires and displays physiological signals, no claims are being made for analysis of the acquired signals with respect to the accuracy, precision and reliability.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131383 · printed Nov 5, 2026
Cite this page
510(k) Report. “K131383: X10 Headset with X-Series Basic Software, X24 Headset with X-Series Basic Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K131383
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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