510(k) · Cleared
ClearedSniff Position Pillows/Popitz Pillows
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aeolus International Corporation · MYB Pillow, Cervical (For Mild Sleep Apnea)
Cleared on Oct 1, 2002 after a 22-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 12 later devices descend from it.
- Decided
- Oct 1, 2002
- Review
- 22 days
- Class
- Class II
- Product code
- MYB
- Recalls
- None
- Predicates
- 0
12 later devices descend from it, 2 citing it directly.
- This deviceK023010 Sniff Position Pillows/Popitz PillowsAeolus International Corporation · 2002
- Descendant · cites it directly · 8 of its ownK033241 BE-Mobile 3-Wheeled Electric Scooter, Model DK S320Tung Keng Enterprise Co., Ltd. · 2003
- Descendant · 2 generations on · 4 of its ownK050792 Landlex, Model S300XCycling and Health Tech. Industry R&D Center · 2005
- Descendant · 3 generations on · 3 of its ownK052378 Proasia, Model L3402Proasia Limited · 2005
- Descendant · cites it directly · 2 of its ownK100160 Zzoma Positional Sleeper Model 001Sleep Specialists, LLC · 2010
- Descendant · 3 generations on · 2 of its ownK060042 Landlex, Model P100XBesteam Technology, Inc. · 2006
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K033241BE-Mobile 3-Wheeled Electric Scooter, Model DK S320Tung Keng Enterprise Co., Ltd. · 2003 · cites it directly8descendants
- K050792Landlex, Model S300XCycling and Health Tech. Industry R&D Center · 2005 · 2 generations on4descendants
- K052378Proasia, Model L3402Proasia Limited · 2005 · 3 generations on3descendants
- K100160Zzoma Positional Sleeper Model 001Sleep Specialists, LLC · 2010 · cites it directly2descendants
- K060042Landlex, Model P100XBesteam Technology, Inc. · 2006 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K023010 | Sniff Position Pillows/Popitz Pillows | Aeolus International Corporation | 2002 | — |
| +1 | K033241 | BE-Mobile 3-Wheeled Electric Scooter, Model DK S320 | Tung Keng Enterprise Co., Ltd. | 2003 | — |
| +2 | K050792 | Landlex, Model S300X | Cycling and Health Tech. Industry R&D Center | 2005 | — |
| +3 | K052378 | Proasia, Model L3402 | Proasia Limited | 2005 | — |
| +1 | K100160 | Zzoma Positional Sleeper Model 001 | Sleep Specialists, LLC | 2010 | — |
| +3 | K060042 | Landlex, Model P100X | Besteam Technology, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2005 | 4 | 0 |
| 2006 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (12)
See all 122 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K033241 (Tung Keng Enterprise Co., Ltd., 2003) has gone furthest, with 8 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?
The Sniff Position Pillows are indicated for the following uses:
1.) May improve the quality of sleep
2.) May improve the symptoms of mild obstructive sleep apnea
3.) May improve snoring
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K023010 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023010: Sniff Position Pillows/Popitz Pillows.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023010
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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