# K140542: Navage Nasal Irrigator, Navage Nose Cleaner

- Pathway: 510(k) (Traditional)
- Applicant: Rhinosystems, Inc.
- Decided: Jun 27, 2014 after 115 days
- Product code: KMA (Irrigator, Powered Nasal)
- Device class: 1
- Regulation: 21 CFR 874.5550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K821481 (1982). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973875: Rinoflow Micronized E.N.T. Wash System, Respironics, Inc. (1998) Summary page 1.
- (no number) Ubimed Cleanoz Nasal Aspirator Kit: named in the summary without a submission number

## Indications for use
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.

Source page: https://510kreport.com/device/K140542
Methodology: https://510kreport.com/methodology