510(k) · Cleared
ClearedX4 System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advanced Brain Monitoring, Inc. · OMC Reduced- Montage Standard Electroencephalograph
Cleared on Jan 31, 2013 as substantially equivalent to K120447 (Advanced Brain Monitoring, Inc., 2012) and 1 other predicate after a 29-day review. Its family tree reaches back 6 generations to 1987. 17 later devices descend from it.
- Decided
- Jan 31, 2013
- Review
- 29 days
- Class
- Class II
- Product code
- OMC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K873535 (1987). 19 ancestors in all. 17 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK873535 Nicolet Expert Sleep/Wake Analysis SystemNicolet Biomedical Instruments · 1987
- 5 generations backK955841 Sleep System for Clinics & ResearchCompumedics Ptd, Ltd. · 1997
- 4 generations backK072014 VitascoreVitascore B.V. · 2007
- 3 generations backK082968 Apneicare Connection Center/Internet AnalysisApneicare, LLC · 2009
- 2 generations backK112514 Apnea Risk Evaluation System (Ares)Advanced Brain Monitoring, Inc. · 2012
- 1 generation backK120447 X4Advanced Brain Monitoring, Inc. · 2012
- This deviceK130013 X4 SystemAdvanced Brain Monitoring, Inc. · 2013
- Descendant · cites it directly · 14 of its ownK131383 X10 Headset with X-Series Basic Software, X24 Headset with X-Series…Advanced Brain Monitoring, Inc. · 2013
- Descendant · 2 generations on · 7 of its ownK141316 Cognision Eeg/EP SystemNeuronetrix Solutions · 2015
- Descendant · 3 generations on · 6 of its ownK171781 eVox SystemEvoke Neuroscience, Inc. · 2017
- Descendant · 3 generations on · 3 of its ownK192753 NeuralScan SystemMedeia, Inc. · 2020
- Descendant · 2 generations on · 3 of its ownK172735 WR19 SystemZeto, Inc. · 2018
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K131383X10 Headset with X-Series Basic Software, X24 Headset with X-Series Basic SoftwareAdvanced Brain Monitoring, Inc. · 2013 · cites it directly14descendants
- K141316Cognision Eeg/EP SystemNeuronetrix Solutions · 2015 · 2 generations on7descendants
- K171781eVox SystemEvoke Neuroscience, Inc. · 2017 · 3 generations on6descendants
- K192753NeuralScan SystemMedeia, Inc. · 2020 · 3 generations on3descendants
- K172735WR19 SystemZeto, Inc. · 2018 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K873535 | Nicolet Expert Sleep/Wake Analysis System | Nicolet Biomedical Instruments | 1987 | — |
| −5 | K955841 | Sleep System for Clinics & Research | Compumedics Ptd, Ltd. | 1997 | — |
| −4 | K072014 | Vitascore | Vitascore B.V. | 2007 | — |
| −3 | K082968 | Apneicare Connection Center/Internet Analysis | Apneicare, LLC | 2009 | — |
| −2 | K112514 | Apnea Risk Evaluation System (Ares) | Advanced Brain Monitoring, Inc. | 2012 | — |
| −1 | K120447 | X4 | Advanced Brain Monitoring, Inc. | 2012 | — |
| 0 (this device) | 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 | — |
| +2 | K141316 | Cognision Eeg/EP System | Neuronetrix Solutions | 2015 | — |
| +3 | K171781 | eVox System | Evoke Neuroscience, Inc. | 2017 | — |
| +3 | K192753 | NeuralScan System | Medeia, Inc. | 2020 | — |
| +2 | K172735 | WR19 System | Zeto, Inc. | 2018 | — |
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 |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 3 | 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 OMC? 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 OMC device
- #1 K251550 NX01 (NX01)score 13.1 · 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 |
|---|---|---|---|
| * | K120447 | X4Summary page 1…Monitoring, Inc. DEVICE: TRADE NAME: X4 System COMMON/USUAL NAME: X4 CLASSIFICATION NAM ES: 882.1400 Electroencephalograph PRODUCT CODE: OMC PREDICATE DEVICE(S): K120447 X4 System K112514 Apnea Risk Evaluation System (ARES), Model 610 31 === P… | 2012 |
| * | K112514 | Apnea Risk Evaluation System (Ares)Summary page 1…DEVICE: TRADE NAME: X4 System COMMON/USUAL NAME: X4 CLASSIFICATION NAM ES: 882.1400 Electroencephalograph PRODUCT CODE: OMC PREDICATE DEVICE(S): K120447 X4 System K112514 Apnea Risk Evaluation System (ARES), Model 610 31… | 2012 |
What descends from it? (17)
See all 172 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 3.0 years on median.
- 1 of the 19 ancestors has a recall of any class.
- Of its descendants, K131383 (Advanced Brain Monitoring, Inc., 2013) has gone furthest, with 14 descendants of its own.
How does its category compare?
All OMC devicesOMC Reduced- 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 · OMC
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OMC
172in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OMC
No recall names OMC since 2007.
Adverse event reports per year · OMC
2in 2025
MAUDE reports naming product code OMC, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 2 | — | 0 | 2 |
| 2024 | 3 | 56 | 0 | 2 |
| 2025 | 3 | 172 | 0 | 2 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The X4 System is intended for prescription use in the home, healthcare facility, or clinical research environment to acquire, record, transmit and display physiological signals from adult patients. The X4 System acquires, records, transmits and displays electroencephalogram (EEG), electrooculogramn (EOG), electrocardiogram (ECG), and/or electromyogram (EMVG), accelerometer, acoustical and photoplethesmographic signals. The X4 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/K130013 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130013: X4 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130013
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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