# K062484: Flaem Nuova RF6 Basic and RF6 Plus Nebulizers

- Pathway: 510(k) (Traditional)
- Applicant: Flaem Nuova S.P.A.
- Decided: Jun 8, 2007 after 287 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 K870027 (1987). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962879: Salterlabs 8660 Series Nebulizer, Salter Labs (1996) Summary page 1.
- K963924: LC Star Reusable Nebulizer 22F50 and LC Star Disposable Nebulizer 22F70, Pari Holding Co. (1996) Summary page 1.
- K991725: Sidestream Nebulizer, Inspired Medical Products, Ltd. (1999) Summary page 1.

## Indications for use
The Flaem Nuova RF6 Basic and RF6 Plus Nebulizers are reusable single patient use nebulizers which are used where a fine aerosol mist of medication must be delivered to a patient for the treatment of respiratory disorders. The Flaem Nuova RF6 Basic and RF6 Plus Nebulizers are intended to be used for both adult and pediatric patients who have been prescribed inhalation therapy or medication in both home health care and hospital use. The Flaem Nuova RF6 Basic and RF6 Plus Nebulizers may be used with compressed air or an air gas source providing air flow between 4 and 10 lmin.

Source page: https://510kreport.com/device/K062484
Methodology: https://510kreport.com/methodology