# K980745: Second Wind Air Purifier

- Pathway: 510(k) (Traditional)
- Applicant: Monagan Ent., Inc.
- Decided: Apr 2, 1999 after 400 days
- Product code: FRA (Purifier, Air, Ultraviolet, Medical)
- Device class: 2
- Regulation: 21 CFR 880.6500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
THCWWMGMIWWWWMM{EMHVAC system, to improve the indoor air quality. The Second Wind air purifier s recommended to be.used In conjunction with a media filter, bumidifylng device, proper controls to run the fan and the scaling of any ductwork. The Second Wind air purifier may be, but not necessarily used in conjunction with a cotoplete IAQ packsge. The use is for anyone concerned with his or her indoor sir quality. The unit is essily installed withiu the forced air furnace and/or the air movement device withio « home or business.

Source page: https://510kreport.com/device/K980745
Methodology: https://510kreport.com/methodology