510(k) · Cleared
ClearedNavage Nasal Irrigator, Navage Nose Cleaner
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rhinosystems, Inc. · KMA Irrigator, Powered Nasal
Cleared on Jun 27, 2014 as substantially equivalent to K973875 (Respironics, Inc., 1998) after a 115-day review. Its family tree reaches back 2 generations to 1982.
- Decided
- Jun 27, 2014
- Review
- 115 days
- Class
- Class I
- Product code
- KMA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K821481 (1982). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 KMA? 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 |
|---|---|---|---|
| * | K973875 | Rinoflow Micronized E.N.T. Wash SystemSummary page 1…rrigator Product Code KMA 21 CFR 880.6740 Vacuum Powered Body Fluid Suction Apparatus Product Code KDQ Predicate Devices: Respironics RinoFlowv E.NT. Nasal Wash System (K973875) Ubimed Cleanoz Nasal Aspirator Kit Device Description: The Navige Nose Cleaner ('Navtige") is a powered nasal irrigator intended… | 1998 |
| * | — | Ubimed Cleanoz Nasal Aspirator Kit Named without a submission number |
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.
What does this lineage say?
- The line of descent spans 32 years and passes through 3 companies; a new generation was cleared every 16.4 years on median.
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K973875.
How does its category compare?
All KMA devicesKMA Irrigator, Powered Nasal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · KMA
1in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · KMA
Too few KMA 510(k)s in any year since 2007 to give a median.
Recalls per year · KMA
1in 2012
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KMA
3in 2025
MAUDE reports naming product code KMA, 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 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 1 | 1 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 4 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Navage Nose Cleaner is intended to help relieve nasal and/or sinus congestion and stuffiness by washing and moisturizing the nasal cavity with a pressure-controlled stream of irrigant rinse.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140542 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140542: Navage Nasal Irrigator, Navage Nose Cleaner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140542
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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