# K980074: 56 Series Aerosol Generator

- Pathway: 510(k) (Traditional)
- Applicant: Project Marketing
- Decided: Jun 12, 1998 after 155 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
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K042483: Invacare Pro, Compact and Portable Desktop (2005), 2 descendants of its own
- 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 56 series Aerosol Generator is for the production of compressed air to operate a nebulizer for the production of medical aerosol for respiratory disorders. The 56 series Aerosol Generator requires a nebulizer and medication for operation. The use of the 56 series Aerosol Generator is for the sole purpose of compressed air production and requires the order of a physician for medical use.

Source page: https://510kreport.com/device/K980074
Methodology: https://510kreport.com/methodology