# K042483: Invacare Pro, Compact and Portable Desktop

- Pathway: 510(k) (Traditional)
- Applicant: Invacare Corporation
- Decided: Jan 6, 2005 after 115 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: 2 generations back to K914836 (1992). 5 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980074: 56 Series Aerosol Generator, Project Marketing (1998) Summary page 5.
- K032170: Transneb Compressor W/Nebulizer, Model 5000, Medical Industries America, Inc. (2004) Summary page 5.

## Most influential descendants
- K072163: Happyneb II, Happyneb Iii, Speedy, Nebby Plus and Myneb, Model 5 (2008), 0 descendants of its own
- K062014: Families of Master Neb, Primo Neb, SC03, Neb Aid, 4.2.Neb, Q03, FJ03, and Walkie-Neb (2007), 0 descendants of its own

## Indications for use
The intended use of the Invacare Pro Nebulizer and the Invacare Compact Nebulizer 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. The Invacare Pro Nebulizer and Compact Nebulizer are indicated for use with any commercially available nebulizer and mouthpiece. The Invacare Pro Nebulizer and Compact Nebulizer are intended for home health care use. The intended use of the Invacare Portable Desktop Nebulizer 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. The Invacare Portable Desktop Nebulizer is used exclusively with its own nebulizer and mouthpiece. The Invacare Portable Desktop Nebulizer is intended for home health care use.

Source page: https://510kreport.com/device/K042483
Methodology: https://510kreport.com/methodology