# K213114: BentrioTM Allergy Blocker

- Pathway: 510(k) (Traditional)
- Applicant: Altamira Therapeutics, Inc.
- Decided: Jun 24, 2022 after 270 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)
- K132520: Nasal Ease Allergy Blocker, Hi-Tech Pharmacal, Inc. (2013) Summary page 4.

## Indications for use
Bentrio is intended to treat hay fever and allergy sufferers by promoting alleviation of mild allergic symptoms (i.e., mild nasal irritation including itchy, runny, or congested nasal passages) triggered by the inhalation of various airborne allergens including indoor and outdoor environmental pollens, house dust, animal hair and dust mites. Application of Bentrio produces a mucous-like gel barrier that coats the nasal membranes, traps inhaled allergens within the nasal cavity and helps with their clearance.

Source page: https://510kreport.com/device/K213114
Methodology: https://510kreport.com/methodology