510(k) · Cleared
ClearedPillowpositive Cervical Pillow
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lifesleep Systems, Inc. · MYB Pillow, Cervical (For Mild Sleep Apnea)
Cleared on Jun 10, 1999 after an 86-day review. The FDA summary names its predicate without a number. 8 later devices descend from it.
- Decided
- Jun 10, 1999
- Review
- 86 days
- Class
- Class II
- Product code
- MYB
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 1 citing it directly.
- This deviceK990871 Pillowpositive Cervical PillowLifesleep Systems, Inc. · 1999
- Descendant · cites it directly · 7 of its ownK052597 Breathex Omega Cpap Device, Model 322Hoffman Laboratories, LLC · 2005
- Descendant · 2 generations on · 5 of its ownK100121 Model 300157 Cpap SystemAeiomed, Inc. · 2010
- Descendant · 3 generations on · 1 of its ownK132127 Transcend AutoSomnetics International, Inc. · 2013
- Descendant · 2 generations on · 1 of its ownK121374 ZI BlowerDeshum Medical · 2013
- Descendant · 4 generations on · 0 of its ownK180388 Transcend 365 miniCPAP SystemSomnetics International, Inc. · 2018
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K052597Breathex Omega Cpap Device, Model 322Hoffman Laboratories, LLC · 2005 · cites it directly7descendants
- K100121Model 300157 Cpap SystemAeiomed, Inc. · 2010 · 2 generations on5descendants
- K132127Transcend AutoSomnetics International, Inc. · 2013 · 3 generations on1descendant
- K121374ZI BlowerDeshum Medical · 2013 · 2 generations on1descendant
- K180388Transcend 365 miniCPAP SystemSomnetics International, Inc. · 2018 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K990871 | Pillowpositive Cervical Pillow | Lifesleep Systems, Inc. | 1999 | — |
| +1 | K052597 | Breathex Omega Cpap Device, Model 322 | Hoffman Laboratories, LLC | 2005 | — |
| +2 | K100121 | Model 300157 Cpap System | Aeiomed, Inc. | 2010 | — |
| +3 | K132127 | Transcend Auto | Somnetics International, Inc. | 2013 | — |
| +2 | K121374 | ZI Blower | Deshum Medical | 2013 | — |
| +4 | K180388 | Transcend 365 miniCPAP System | Somnetics International, Inc. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 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? (4)
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 |
|---|---|---|---|
| * | — | Dr. Jonathan A. Parker’s PM Positioner Named without a submission number | |
| * | — | Dr. Jonathan A. Parker’s Adjustable PM Positioner Named without a submission number | |
| * | — | LifeSleep PillowPositive for snoring Named without a submission number | |
| * | — | Ortho-Rest Company’s A-Just Right Pillow Named without a submission number |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K052597 | Breathex Omega Cpap Device, Model 322 | 2005 | 7 |
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?
- Of its descendants, K052597 (Hoffman Laboratories, LLC, 2005) has gone furthest, with 7 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.
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?
PillowPositive Cervical Pillow (“PillowPositive”) is indicated for the reduction of symptoms (apneas and hypopneas) associated with mild obstructive sleep apnea.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K990871 · printed Nov 6, 2026
Cite this page
510(k) Report. “K990871: Pillowpositive Cervical Pillow.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K990871
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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