510(k) · Cleared
ClearedCerebra Sleep System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cerebra Medical, Ltd. · OLV Standard Polysomnograph With Electroencephalograph
Cleared on Jul 6, 2022 as substantially equivalent to K152040 (Advanced Brain Monitoring, Inc., 2015) and 1 other predicate after a 289-day review. Its family tree reaches back 8 generations to 1987.
- Decided
- Jul 6, 2022
- Review
- 289 days
- Class
- Class II
- Product code
- OLV
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K873535 (1987). 34 ancestors in all. No later device cites it as a predicate yet.
- 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 backK152040 X8 System - Sleep Profiler (SP40), X8 System - Sleep Profiler PSG2…Advanced Brain Monitoring, Inc. · 2015
- This deviceK213007 Cerebra Sleep SystemCerebra Medical, Ltd. · 2022
View 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 | K152040 | X8 System - Sleep Profiler (SP40), X8 System - Sleep Profiler PSG2 (SP29), X8… | Advanced Brain Monitoring, Inc. | 2015 | — |
| 0 (this device) | K213007 | Cerebra Sleep System | Cerebra Medical, Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1994 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2011 | 3 | 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 OLV? 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 OLV device
- #1 K241288 Noxturnal Webscore 17.3 · 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 |
|---|---|---|---|
| * | K152040 | X8 System - Sleep Profiler (SP40), X8 System - Sleep Profiler PSG2 (SP29), X8 System -…Summary page 4…System – Sleep Profiler PSG2 (SP29), X8 System - Stat X8 (XS29) Primary Predicate 510(k): K152040 Secondary Predicate Manufacturer: Younes Sleep Technologies Secondary Predicate Trade Name:… | 2015 |
| * | K112102 | Michele Sleep Scoring SystemsSummary page 4…Younes Sleep Technologies Secondary Predicate Trade Name: Michele Sleep Scoring Systems Secondary Predicate 510(k): K112102 No reference devices were used in this submission. IV. DEVICE DESCRIPTION The Cerebra Sleep System is an integrated diagnost… | 2011 |
| † | K072201 | Compumedics Somte PSG Recording System | 2008 |
| † | K040595 | ALICE 5 | 2004 |
| † | K120888 | PSG-1100 Sleep Diagnostic System | 2012 |
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 35 years and passes through 6 companies; a new generation was cleared every 3.0 years on median.
- 2 of the 34 ancestors have a recall of any class.
How does its category compare?
All OLV devicesOLV Standard Polysomnograph With Electroencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · OLV
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OLV
141in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OLV
No recall names OLV since 2007.
Adverse event reports per year · OLV
1in 2025
MAUDE reports naming product code OLV, 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 | 2 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 2 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 4 |
| 2017 | 3 | 83 | 0 | 0 |
| 2018 | 3 | 141 | 0 | 3 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 1 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 2 | — | 0 | 2 |
| 2025 | 1 | — | 0 | 1 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Cerebra Sleep System is an integrated diagnostic platform that acquires, transmits, analyzes, and displays physiological signals from adult patients, and then provides for scoring (automatic and manual), editing, and generating reports. The system uses polysomnography (PSG) to record the electroencephalogram (EEG), electrooculogram (EOG), electrocardiogram (ECG), electromyogram (EMG), accelerometry, acoustic signals, nasal airflow, thoracic and…
Read the full statement (138 words)
The Cerebra Sleep System is an integrated diagnostic platform that acquires, transmits, analyzes, and displays physiological signals from adult patients, and then provides for scoring (automatic and manual), editing, and generating reports. The system uses polysomnography (PSG) to record the electroencephalogram (EEG), electrooculogram (EOG), electrocardiogram (ECG), electromyogram (EMG), accelerometry, acoustic signals, nasal airflow, thoracic and abdomen respiratory effort, pulse rate, and oxyhemoglobin saturation, depending on the sleep study configuration. The Cerebra Sleep System is for prescription use in a home or healthcare facility.
The Cerebra Sleep System is intended to be used as a support tool by physicians and PSG technologists to aid in the evaluation and diagnosis of sleep disorders. It is intended to provide sleep-related information that is interpreted by a qualified physician to render findings and/or diagnosis, but it does not directly generate a diagnosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213007 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213007: Cerebra Sleep System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213007
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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