# K062014: Families of Master Neb, Primo Neb, SC03, Neb Aid, 4.2.Neb, Q03, FJ03, and Walkie-Neb

- Pathway: 510(k) (Traditional)
- Applicant: Flaem Nuova S.P.A.
- Decided: Mar 22, 2007 after 248 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). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013027: Mister Neb Nebulizer Compressor, with Nebulizer, Model HS123, Respironics Healthscan, Inc. (2001) Summary page 1.
- K922623: Nebulizer System, Healthdyne, Inc. (1992) Summary page 1.
- K042483: Invacare Pro, Compact and Portable Desktop, Invacare Corporation (2005) Summary page 1.
- K992285: Salter Aire Compressor, Salter Labs (2000) Summary page 1.

## Indications for use
The nebulizer compressors Master Neb, Primo Neb, SCO3, Neb Aid, 4.2.Neb, FJO3, and Q03 are intended to provide a source of compressed air for medical purposes, to be used in home health care and hospital use. The Walkie-Neb model is intended to be used only in home health care. These devices are indicated for use with all commercially available small volume pneumatic nebulizers, to produce a fine aerosol mist of medication for respiratory therapy, for both adult and pediatric patients who have been prescribed inhalation therapy or medication.

Source page: https://510kreport.com/device/K062014
Methodology: https://510kreport.com/methodology