510(k) · Cleared
ClearedNight Shift
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advanced Brain Monitoring, Inc. · MYB Pillow, Cervical (For Mild Sleep Apnea)
Cleared on May 29, 2014 as substantially equivalent to K100160 (Sleep Specialists, LLC, 2010) and 1 other predicate after a 125-day review. Its family tree reaches back 5 generations to 1987. 1 later device descends from it.
- Decided
- May 29, 2014
- Review
- 125 days
- Class
- Class II
- Product code
- MYB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K873535 (1987). 21 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK873535 Nicolet Expert Sleep/Wake Analysis SystemNicolet Biomedical Instruments · 1987
- 4 generations backK955841 Sleep System for Clinics & ResearchCompumedics Ptd, Ltd. · 1997
- 3 generations backK072014 VitascoreVitascore B.V. · 2007
- 2 generations backK082968 Apneicare Connection Center/Internet AnalysisApneicare, LLC · 2009
- 1 generation backK112514 Apnea Risk Evaluation System (Ares)Advanced Brain Monitoring, Inc. · 2012
- This deviceK140190 Night ShiftAdvanced Brain Monitoring, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK180608 Lunoa SystemNightbalance BV · 2018
Most influential descendants
Showing 1 of 1 · See all- K180608Lunoa SystemNightbalance BV · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K873535 | Nicolet Expert Sleep/Wake Analysis System | Nicolet Biomedical Instruments | 1987 | — |
| −4 | K955841 | Sleep System for Clinics & Research | Compumedics Ptd, Ltd. | 1997 | — |
| −3 | K072014 | Vitascore | Vitascore B.V. | 2007 | — |
| −2 | K082968 | Apneicare Connection Center/Internet Analysis | Apneicare, LLC | 2009 | — |
| −1 | K112514 | Apnea Risk Evaluation System (Ares) | Advanced Brain Monitoring, Inc. | 2012 | — |
| 0 (this device) | K140190 | Night Shift | Advanced Brain Monitoring, Inc. | 2014 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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 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? (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 |
|---|---|---|---|
| * | K100160 | Zzoma Positional Sleeper Model 001Summary page 3…t to Predicate Device Specification Night Shift ZZOMA Positional AIRES Model 610 Sleeper (K100160) (K112514) indications The Night Shift is The ZZOMA Positional The Apnea Risk… | 2010 |
| * | K112514 | Apnea Risk Evaluation System (Ares)Summary page 3…Night Shift ZZOMA Positional AIRES Model 610 Sleeper (K100160) (K112514) indications The Night Shift is The ZZOMA Positional The Apnea Risk for Use indicated for… | 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 |
|---|---|---|---|
| K180608 | Lunoa System | 2018 | 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 27 years and passes through 5 companies; a new generation was cleared every 3.0 years on median.
- 1 of the 21 ancestors has a recall of any class.
- Of its descendants, K180608 (Nightbalance BV, 2018) has gone furthest, with 0 descendants of its own.
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. 2014, 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 Night Shift is indicated for prescription use for the treatment of adult patients with positional obstructive sleep apnea with a non-supine apnea-hypopnea index < 20, and to reduce or alleviate snoring. It records position, movement, and sound so that positional changes in sleep quality and snoring can be assessed.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140190 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140190: Night Shift.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140190
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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