# K973875: Rinoflow Micronized E.N.T. Wash System

- Pathway: 510(k) (Traditional)
- Applicant: Respironics, Inc.
- Decided: Jan 26, 1998 after 108 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.
17 later devices descend from it; 2 cite it directly.
0 of 19 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.

## Most influential descendants
- K082762: Aardvark Nasal Irrigation and Aspiration Device (2008), 15 descendants of its own
- K090379: Avita Nasal Aspirator, Model, NS1 Series (2010), 13 descendants of its own
- K180863: FORA NAS100 Electronic Nasal Aspirator, Electronic Nasal Aspirator (2018), 10 descendants of its own
- K222547: Electric nasal aspirator (2022), 9 descendants of its own
- K233901: Baby Nasal Aspirator (KA1006, KA1001, KA1005, NASA005, NASA006, NASA008, NASA009) (2024), 3 descendants of its own

## Indications for use
The 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 conditions 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: * Rhinitis (as a symptom of colds, allergies, etc.) * 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. RinoFlow Micronized E.N.T. Wash System is intended to be used by adults and pediatrics (age >3) in the home or doctor’s office, and is available over-the-counter.

Source page: https://510kreport.com/device/K973875
Methodology: https://510kreport.com/methodology