510(k) · Cleared
ClearedChin-UP Strip
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dale Miller, Inc. - the Chin-Up Company · LWF Dilator, Nasal
Cleared on Sep 10, 2004 after a 197-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Sep 10, 2004
- Review
- 197 days
- Class
- Class I
- Product code
- LWF
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
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 LWF? 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?
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.
How does its category compare?
All LWF devicesLWF Dilator, Nasal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LWF
1in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · LWF
Too few LWF 510(k)s in any year since 2007 to give a median.
Recalls per year · LWF
No recall names LWF since 2007.
Adverse event reports per year · LWF
8in 2024
MAUDE reports naming product code LWF, 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 | 5 |
| 2008 | 0 | — | 0 | 4 |
| 2009 | 0 | — | 0 | 3 |
| 2010 | 0 | — | 0 | 4 |
| 2011 | 0 | — | 0 | 9 |
| 2012 | 1 | — | 0 | 12 |
| 2013 | 0 | — | 0 | 10 |
| 2014 | 0 | — | 0 | 12 |
| 2015 | 0 | — | 0 | 41 |
| 2016 | 0 | — | 0 | 39 |
| 2017 | 0 | — | 0 | 13 |
| 2018 | 1 | — | 0 | 15 |
| 2019 | 0 | — | 0 | 13 |
| 2020 | 0 | — | 0 | 6 |
| 2021 | 0 | — | 0 | 4 |
| 2022 | 0 | — | 0 | 5 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 8 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Chin-Up Strip promotes and enhances nasal breathing to help Breathe Right nasal strips to reduce or eliminate snoring.
The Chin-Up Strip supports the chin ('nandible) during sleep, thereby promoting and enhancing nasal breathing by reducing mouth breathing and oral venting.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K040491 · printed Nov 3, 2026
Cite this page
510(k) Report. “K040491: Chin-UP Strip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K040491
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026