510(k) · Cleared
ClearedFlaem Nuova RF6 Basic and RF6 Plus Nebulizers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Flaem Nuova S.P.A. · CAF Nebulizer (Direct Patient Interface)
Cleared on Jun 8, 2007 as substantially equivalent to K962879 (Salter Labs, 1996) and 2 other predicates after a 287-day review. Its family tree reaches back 2 generations to 1987.
- Decided
- Jun 8, 2007
- Review
- 287 days
- Class
- Class II
- Product code
- CAF
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K870027 (1987). 6 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K870027 | Hand Held Pheumatic Powered (Disposable) Nebulizer | Salter Labs | 1987 | 1 |
| −1 | K962879 | Salterlabs 8660 Series Nebulizer | Salter Labs | 1996 | 1 |
| 0 (this device) | K062484 | Flaem Nuova RF6 Basic and RF6 Plus Nebulizers | Flaem Nuova S.P.A. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 2 | 0 |
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in CAF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new CAF device
- #1 K260270 FindAir ONE for pMDI (FAO-MDI-V12-GRE-001)score 13.2 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K962879 | Salterlabs 8660 Series NebulizerSummary page 1…The Flaem Nuova RF6 Basic and RF6 Plus Nebulizers are substantially equivalent to a combination of the following devices: VSalter Labs, 8660 Series- K962879 VPani LC STAR Reusable Nebulizer 22F50 - K963924 V Medic-Aid - Sidestream Nebulizer - K99 1725 4. Devi… | 1996 |
| * | K963924 | LC Star Reusable Nebulizer 22F50 and LC Star Disposable Nebulizer 22F70Summary page 1…ntially equivalent to a combination of the following devices: VSalter Labs, 8660 Series- K962879 VPani LC STAR Reusable Nebulizer 22F50 - K963924 V Medic-Aid - Sidestream Nebulizer - K99 1725 4. Device Description The Flaem Nuova RF6 Basic and RF6 Plus… | 1996 |
| * | K991725 | Sidestream NebulizerSummary page 1…owing devices: VSalter Labs, 8660 Series- K962879 VPani LC STAR Reusable Nebulizer 22F50 - K963924 V Medic-Aid - Sidestream Nebulizer - K99 1725 4. Device Description The Flaem Nuova RF6 Basic and RF6 Plus Nebulizers are hand-held, reusable, single patien… | 1999 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 2 companies; a new generation was cleared every 10.6 years on median.
- 2 of the 6 ancestors have a recall of any class.
- 2 other devices also cite its predicate K962879.
How does its category compare?
All CAF devicesCAF Nebulizer (Direct Patient Interface): FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · CAF
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CAF
211in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CAF
1in 2018
Class I (13 since 2007) Class II/III not classified
Adverse event reports per year · CAF
191in 2025
MAUDE reports naming product code CAF, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 18 | 98 | 1 | 26 |
| 2008 | 12 | 123 | 0 | 11 |
| 2009 | 8 | 163 | 0 | 15 |
| 2010 | 10 | 114 | 0 | 37 |
| 2011 | 10 | 157 | 1 | 237 |
| 2012 | 9 | 126 | 0 | 138 |
| 2013 | 9 | 238 | 0 | 217 |
| 2014 | 9 | 151 | 5 | 123 |
| 2015 | 8 | 186 | 3 | 166 |
| 2016 | 5 | 186 | 1 | 201 |
| 2017 | 8 | 253 | 14 (13) | 256 |
| 2018 | 9 | 161 | 1 | 162 |
| 2019 | 3 | 266 | 0 | 185 |
| 2020 | 6 | 219 | 0 | 117 |
| 2021 | 8 | 324 | 0 | 161 |
| 2022 | 4 | 176 | 0 | 55 |
| 2023 | 8 | 279 | 0 | 107 |
| 2024 | 4 | 251 | 0 | 102 |
| 2025 | 7 | 211 | 0 | 191 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062484 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062484: Flaem Nuova RF6 Basic and RF6 Plus Nebulizers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062484
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026