# K134003: Rhinix Nasal Filter

- Pathway: 510(k) (Traditional)
- Applicant: Rhinix Aps
- Decided: Sep 4, 2014 after 251 days
- Product code: NUP (Cream, Nasal, Topical, Mechanical Allergen Particle Barrier)
- Device class: 2
- Regulation: 21 CFR 880.5045
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K002338 (2001). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120894: Haymax, Haymax Limited (2012) Summary page 4.

## Indications for use
RHINIX™ nasal filter for patients aged 6 years and older, with properties that allow unimpeded nasal breathing, is for the prevention or alleviation of seasonal allergic rhinitis (hay fever) and for seasonal or perennial allergies to other airborne allergens with a similar size fraction to grass pollen allergens.

Source page: https://510kreport.com/device/K134003
Methodology: https://510kreport.com/methodology