# K963550: Rinoflow Micronized E.N..T. Wash Sytstem

- Pathway: 510(k) (Traditional)
- Applicant: Respironics, Inc.
- Decided: Nov 1, 1996 after 57 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: 1 generation back to K821481 (1982). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K821481: Nasal-Throat Spray Irrigation Instrum., Ethicare Products (1982) Summary page 1.

## Indications for use
RinoFlow Micronized E.N.T. Wash System aerosolizes solutions intended for nasal and sinus irrigation and humidification of the upper respiratory tract. RinoFlow is used to treat condifions and disorders of the upper respiratory tract where homeostasis of the nasal mucosa is disturbed, resulting in symptoms such as catarrh, and mucopurulent or crusty secretions. Such conditions and disorders include: e Rhinitis e Both Acute and Chronic Sinusitis RinoFlow Micronized E.N.T. Wash System should be used with a physiological saline solution. "Tap" water is not recommended.

Source page: https://510kreport.com/device/K963550
Methodology: https://510kreport.com/methodology