# K090730: Akita Jet

- Pathway: 510(k) (Traditional)
- Applicant: Activaero America, Inc.
- Decided: Nov 13, 2009 after 239 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). 16 ancestors in all.
No later device cites it as a predicate yet.
1 of 17 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 2.
- K060399: LC Sprint Nebulizer, Pari Innovative Manufacturers, Inc. (2006) Summary page 1.
- K935693: Autoneb Breath Actuated Controller and Accessory Kit, Vortran Medical Technology 1, Inc. (1994) Summary page 1.

## Indications for use
Thie AKITA JET is a nebulizer system that will be used with patients for whom doctors have prescribed medication (except pentamidine) for nebulization in the home care, nursing home, sub-acute institution, or hospital environment.

Source page: https://510kreport.com/device/K090730
Methodology: https://510kreport.com/methodology