510(k) · Cleared
ClearedLunoa System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nightbalance BV · MYB Pillow, Cervical (For Mild Sleep Apnea)
Cleared on Jun 5, 2018 as substantially equivalent to K140190 (Advanced Brain Monitoring, Inc., 2014) after a 90-day review. Its family tree reaches back 6 generations to 1987.
- Decided
- Jun 5, 2018
- Review
- 90 days
- Class
- Class II
- Product code
- MYB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K873535 (1987). 22 ancestors in all. No later device cites it as a predicate yet.
- 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 backK140190 Night ShiftAdvanced Brain Monitoring, Inc. · 2014
- This deviceK180608 Lunoa SystemNightbalance BV · 2018
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 | K140190 | Night Shift | Advanced Brain Monitoring, Inc. | 2014 | — |
| 0 (this device) | K180608 | Lunoa System | Nightbalance BV | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 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 MYB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K140190 | Night ShiftSummary page 4…Name Manufacturer 510(k)a # Night Shift Advanced Brain Monitoring K140190 IV. DEVICE DESCRIPTION The Lunoa System is a rechargeable battery-operated medical device, worn around the chest… | 2014 |
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 31 years and passes through 6 companies; a new generation was cleared every 4.0 years on median.
- 1 of the 22 ancestors has a recall of any class.
How does its category compare?
All MYB devicesMYB Pillow, Cervical (For Mild Sleep Apnea): FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · MYB
1in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · MYB
Too few MYB 510(k)s in any year since 2007 to give a median.
Recalls per year · MYB
No recall names MYB since 2007.
Adverse event reports per year · MYB
1in 2025
MAUDE reports naming product code MYB, 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 | 2 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Lunoa System is indicated for prescription use for the treatment of adult patients with positional obstructive sleep apnea with a non-supine apnea-hypopnea index <20. It records position and movement so that positional changes in sleep quality can be assessed.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180608 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180608: Lunoa System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180608
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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