# K142059: Fox Mobile

- Pathway: 510(k) (Traditional)
- Applicant: Vectura GmbH
- Decided: Jan 9, 2015 after 164 days
- Product code: CAF (Nebulizer (Direct Patient Interface))
- Device class: 2
- Regulation: 21 CFR 868.5630
- 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 K933535 (1994). 14 ancestors in all.
No later device cites it as a predicate yet.
1 of 15 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072019: AKITA2 Apixneb, Activaero America, Inc. (2007) Summary page 5.
- K935693: Autoneb Breath Actuated Controller and Accessory Kit, Vortran Medical Technology 1, Inc. (1994) Summary page 5.

## Indications for use
The FOX MOBILE inhalation system is a nebulizer system that will be used with patients for whom doctors have prescribed medication for nebulization in the home care, nursing home, sub-acute institution, or hospital environments. It is intended for patients 3 years and older who can coordinate breathing.

Source page: https://510kreport.com/device/K142059
Methodology: https://510kreport.com/methodology