# K072163: Happyneb II, Happyneb Iii, Speedy, Nebby Plus and Myneb, Model 5

- Pathway: 510(k) (Traditional)
- Applicant: 3A Health Care S.R.L.
- Decided: Mar 6, 2008 after 213 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: 3 generations back to K914836 (1992). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K922623: Nebulizer System, Healthdyne, Inc. (1992) Summary page 2.
- K042483: Invacare Pro, Compact and Portable Desktop, Invacare Corporation (2005) Summary page 2.
- K992285: Salter Aire Compressor, Salter Labs (2000) Summary page 2.
- K964078: 3050 Sport-Neb, Medical Industries America, Inc. (1997) Summary page 2.
- K870027: Hand Held Pheumatic Powered (Disposable) Nebulizer, Salter Labs (1987) Summary page 2.
- K991725: Sidestream Nebulizer, Inspired Medical Products, Ltd. (1999) Summary page 2.
- K963924: LC Star Reusable Nebulizer 22F50 and LC Star Disposable Nebulizer 22F70, Pari Holding Co. (1996) Summary page 2.

## Indications for use
The intended use of the Happyneb II, Happyneb III, Speedy, Nebby Plus and the Myneb is to spray liquids in aerosol form into gases that are delivered directly to adult or pediatric patients who have been prescribed inhalation therapy or medication. Each of these devices must be used exclusively with their own nebulizer and mouthpiece. The devices Happyneb II, Happyneb III, Speedy, and the Nebby Plus are intended to be used primarily by patients in the home care market, although they may also be used by trained hospital staff personnel as well. The Myneb model is intended to be used only in home health care. The Happyneb II, Happyneb III, Speedy, Nebby Plus and the Myneb are intended for multiple use, are non-sterile and for use with pharmaceutical products which are under physician prescription.

Source page: https://510kreport.com/device/K072163
Methodology: https://510kreport.com/methodology