510(k) · Cleared
ClearedMaxair Nasal Dilator System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hnl Technologies · LWF Dilator, Nasal
Cleared on Sep 9, 1998 after a 20-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Sep 9, 1998
- Review
- 20 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 MaxAir™ Nasal Dilator is intended to be used to enhance the flow of air through the nose. The nasal dilator is designed to pull on the outer lateral wall of the nasal passage which in tumn will reduce the resistance to air flow through the nasal passage during breathinléf*The MaxAir™ Nasal Dilator's uses include, but are not limited to persons with temporary symptoms of nasal congestion which may be caused by colds, deviated septums, allergic rhinitis, and alar and valve insufficiency. The reduction of resistance to air flow in the nasal passage can also reduce the onset of snoring due to restrictions to air flow through the nasal passages.
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/K982929 · printed Nov 4, 2026
Cite this page
510(k) Report. “K982929: Maxair Nasal Dilator System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982929
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026