510(k) · Cleared
ClearedZzoma Positional Sleeper Model 001
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sleep Specialists, LLC · MYB Pillow, Cervical (For Mild Sleep Apnea)
Cleared on May 11, 2010 as substantially equivalent to K040161 (Sleep Devices, Inc., 2004) and 1 other predicate after a 111-day review. Its family tree reaches back 1 generation to 2002. 2 later devices descend from it.
- Decided
- May 11, 2010
- Review
- 111 days
- Class
- Class II
- Product code
- MYB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K023010 (2002). 2 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK023010 Sniff Position Pillows/Popitz PillowsAeolus International Corporation · 2002
- This deviceK100160 Zzoma Positional Sleeper Model 001Sleep Specialists, LLC · 2010
- Descendant · cites it directly · 1 of its ownK140190 Night ShiftAdvanced Brain Monitoring, Inc. · 2014
- Descendant · 2 generations on · 0 of its ownK180608 Lunoa SystemNightbalance BV · 2018
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K023010 | Sniff Position Pillows/Popitz Pillows | Aeolus International Corporation | 2002 | — |
| 0 (this device) | K100160 | Zzoma Positional Sleeper Model 001 | Sleep Specialists, LLC | 2010 | — |
| +1 | K140190 | Night Shift | Advanced Brain Monitoring, Inc. | 2014 | — |
| +2 | K180608 | Lunoa System | Nightbalance BV | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K040161 | Sona PillowSummary page 1…tional Sleeper device is substantially equivalent to the predicate device described herein with respect to indications for use: *Sleep Devices, Inc, Sona Pillow - K0401 61 Aeolus International Corporation, Sniff Position Pillows/Popitz Pillows - K023010 The predicate devices (Sona Pillow and… | 2004 |
| * | K023010 | Sniff Position Pillows/Popitz PillowsSummary page 1…with respect to indications for use: *Sleep Devices, Inc, Sona Pillow - K0401 61 Aeolus International Corporation, Sniff Position Pillows/Popitz Pillows - K023010 The predicate devices (Sona Pillow and Sniff Position Biollows/Popitz Pillows) are commercially available and marketed Class 11de… | 2002 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140190 | Night Shift | 2014 | 1 |
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?
- None of the 2 ancestors has a recall.
- Of its descendants, K140190 (Advanced Brain Monitoring, Inc., 2014) has gone furthest, with 1 descendant 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. 2010, 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 ZZOMA Positional Sleeper is indicated for use and intended for professional use for the treatment of mild to moderate, predominantly positional obstructive sleep apnea (OSA) and to reduce or alleviate snoring.
The ZZOMA Positional Sleeper is intended for use by professional healthcare personnel trained in its use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100160 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100160: Zzoma Positional Sleeper Model 001.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100160
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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