# K981841: Breathe Easy, Models AD and CD

- Pathway: 510(k) (Traditional)
- Applicant: Respiraid, Ltd.
- Decided: Oct 13, 1998 after 140 days
- Product code: FRF (Cleaner, Air, Medical Recirculating)
- 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: 1 generation back to K872359 (1987). 1 ancestor in all.
10 later devices descend from it; 3 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K872359: Enviracaire Model EV-1, Enviracaire Corp. (1987) Summary page 2.

## Most influential descendants
- K042610: DR. Theiss Alergol Pollen Blocker Cream (2005), 7 descendants of its own
- K053625: Nasalguard (2006), 6 descendants of its own
- K132520: Nasal Ease Allergy Blocker (2013), 3 descendants of its own
- K170848: Alzair Allergy Blocker (2017), 1 descendant of its own
- K120894: Haymax (2012), 1 descendant of its own

## Indications for use
The BREATHE EASY device is a medical recirculating air cleaner designed to remove airborne particles and allergens, such as: dust, smoke, pollen, mold spores, animal hair and dander, dust mites, and harmful fibers, that may lead to allergic reactions.

Source page: https://510kreport.com/device/K981841
Methodology: https://510kreport.com/methodology