510(k) · Cleared
ClearedX8 System - Sleep Profiler (SP40), X8 System - Sleep Profiler PSG2 (SP29), X8 System - Stat X8 (XS29)
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 Oct 30, 2015 as substantially equivalent to K130013 (Advanced Brain Monitoring, Inc., 2013) after a 100-day review. Its family tree reaches back 7 generations to 1987. 1 later device descends from it.
- Decided
- Oct 30, 2015
- Review
- 100 days
- Class
- Class II
- Product code
- OMC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K873535 (1987). 20 ancestors in all. 1 later device descends from it, 1 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 deviceK152040 X8 System - Sleep Profiler (SP40), X8 System - Sleep Profiler PSG2…Advanced Brain Monitoring, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK213007 Cerebra Sleep SystemCerebra Medical, Ltd. · 2022
Most influential descendants
Showing 1 of 1 · See all- K213007Cerebra Sleep SystemCerebra Medical, Ltd. · 2022 · cites it directly0descendants
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) | K152040 | X8 System - Sleep Profiler (SP40), X8 System - Sleep Profiler PSG2 (SP29), X8… | Advanced Brain Monitoring, Inc. | 2015 | — |
| +1 | K213007 | Cerebra Sleep System | Cerebra Medical, Ltd. | 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 |
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? (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 4…p Profiler PSG2, X8 Stat) COMMON/USUAL NAME: X8 CLASSIFICATION NAMES: 882.1400 Electroencephalograph REVIEW PANEL: Neurology PRODUCT CODE: OMC PREDICATE DEVICE(S): K130013 X4 System 15 Advanced Brain Monitorin… | 2013 |
| † | K112514 | Apnea Risk Evaluation System (Ares) | 2012 |
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 |
|---|---|---|---|
| K213007 | Cerebra Sleep System | 2022 | 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 28 years and passes through 5 companies; a new generation was cleared every 2.7 years on median.
- 1 of the 20 ancestors has a recall of any class.
- Of its descendants, K213007 (Cerebra Medical, Ltd., 2022) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K130013.
How does its category compare?
All OMC devicesOMC Reduced- Montage Standard Electroencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 X8 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. All X8 models (SP40, SP29, and XS29) acquire, record, transmit, and/or display electroencephalogram (EEG), electrooculogram (EOG), electrocardiogram (ECG), and/or electromyogram (EMG) signals, with optional accelerometer, acoustical, and photoplethysmographic…
Read the full statement (111 words)
The X8 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. All X8 models (SP40, SP29, and XS29)
acquire, record, transmit, and/or display electroencephalogram (EEG), electrooculogram (EOG), electrocardiogram
(ECG), and/or electromyogram (EMG) signals, with optional accelerometer, acoustical, and photoplethysmographic
signals. Model SP29 additionally includes a nasal pressure transducer and cannula (for airflow), thoracic and abdomen
respiratory effort, and pulse rate and oxyhemoglobin saturation from the finger. The X8 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/K152040 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152040: X8 System - Sleep Profiler (SP40), X8 System - Sleep Profiler PSG2 (SP29), X8 System - Stat X8 (XS29).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152040
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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