# K072019: AKITA2 Apixneb

- Pathway: 510(k) (Traditional)
- Applicant: Activaero America, Inc.
- Decided: Nov 5, 2007 after 105 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: 4 generations back to K933535 (1994). 13 ancestors in all.
3 later devices descend from it; 3 cite it directly.
1 of 17 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052941: I-Neb Insight Aad System, Profile Therapeutics Plc (2005) Summary page 1.
- K030747: Prodose Aad System, Profile Therapeutics Plc (2004) Summary page 1.
- K033833: Eflow Electronic Inhaler/Nebulizer, Pari Innovative Manufacturers, Inc. (2004) Summary page 1.
- K935693: Autoneb Breath Actuated Controller and Accessory Kit, Vortran Medical Technology 1, Inc. (1994) Summary page 1.

## Most influential descendants
- K142059: Fox Mobile (2015), 0 descendants of its own
- K102454: I-Neb Aad System with Tim; I-Neb Insight Aad System (2011), 0 descendants of its own
- K090730: Akita Jet (2009), 0 descendants of its own

## Indications for use
The AKITA 2 APIXNEB is a nebulizer system that will be used with patients for whom doctors have prescribed medication for nebulization in tile home care, nursing home, sub-acute institution, or hospital environment. The AKITA 2 APIXNEB is intended for patients 3 years and older who can coordinate breathing.

Source page: https://510kreport.com/device/K072019
Methodology: https://510kreport.com/methodology