# K130702: Airsonett Air-4

- Pathway: 510(k) (Traditional)
- Applicant: Airsonett AB
- Decided: Jul 23, 2013 after 130 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: 3 generations back to K872359 (1987). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081062: Airsonnett Airshower Air 3, Airsonett, Inc. (2008) Summary page 1.
- K981841: Breathe Easy, Models AD and CD, Respiraid, Ltd. (1998) Summary page 1.

## Indications for use
The Airsonett AJR-4 is a Mobile Mir Cleaner intended to be used to remove particles from the air for medical purposes. The device is intended for home use only.

Source page: https://510kreport.com/device/K130702
Methodology: https://510kreport.com/methodology