# K120894: Haymax

- Pathway: 510(k) (Traditional)
- Applicant: Haymax Limited
- Decided: May 17, 2012 after 55 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: 5 generations back to K002338 (2001). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053625: Nasalguard, Trutek Corp (2006) Summary page 1.
- K042610: DR. Theiss Alergol Pollen Blocker Cream, Dr. Theiss Naturwaren GmbH (2005) Summary page 1.

## Most influential descendants
- K134003: Rhinix Nasal Filter (2014), 0 descendants of its own

## Indications for use
HayMax m organic pollen barrier balm is intended to promote alleviation of mild allergic symptons, (iLe, mild nasal irritation, including itchy, runny, or congested nasal passages), triggered by the inhalation of various airborne allergens including grass and tree pollen, house dust mite and animal dander.

Source page: https://510kreport.com/device/K120894
Methodology: https://510kreport.com/methodology