# KMA: Irrigator, Powered Nasal

- Device class: 1; regulation: 21 CFR 874.5550; FDA's rule: 510(k) exempt
- FDA decisions: 5
- Recalls: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 1982: 1
- 1995: 1
- 1996: 1
- 1998: 1
- 2014: 1

## Most-cited predicates
- K973875: Rinoflow Micronized E.N.T. Wash System (1998), cited by 2

Source page: https://510kreport.com/product-code/KMA
Data by year (CSV): https://510kreport.com/product-code/KMA.csv