510(k) · Cleared
ClearedHappyneb II, Happyneb Iii, Speedy, Nebby Plus and Myneb, Model 5
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3A Health Care S.R.L. · CAF Nebulizer (Direct Patient Interface)
Cleared on Mar 6, 2008 as substantially equivalent to K922623 (Healthdyne, Inc., 1992) and 6 other predicates after a 213-day review. Its family tree reaches back 3 generations to 1992.
- Decided
- Mar 6, 2008
- Review
- 213 days
- Class
- Class II
- Product code
- CAF
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 3 generations to K914836 (1992). 14 ancestors in all, the oldest K870027 (1987). No later device cites it as a predicate yet.
- Root · 3 generations backK914836 Omron Compressor Nebulizer- Model NE-C09Omron Healthcare, Inc. · 1992
- 2 generations backK032170 Transneb Compressor W/Nebulizer, Model 5000Medical Industries America, Inc. · 2004
- 1 generation backK042483 Invacare Pro, Compact and Portable DesktopInvacare Corporation · 2005
- This deviceK072163 Happyneb II, Happyneb Iii, Speedy, Nebby Plus and Myneb, Model 53A Health Care S.R.L. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K914836 | Omron Compressor Nebulizer- Model NE-C09 | Omron Healthcare, Inc. | 1992 | — |
| −2 | K032170 | Transneb Compressor W/Nebulizer, Model 5000 | Medical Industries America, Inc. | 2004 | — |
| −1 | K042483 | Invacare Pro, Compact and Portable Desktop | Invacare Corporation | 2005 | — |
| 0 (this device) | K072163 | Happyneb II, Happyneb Iii, Speedy, Nebby Plus and Myneb, Model 5 | 3A Health Care S.R.L. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1992 | 3 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 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? (7)
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 |
|---|---|---|---|
| * | K922623 | Nebulizer SystemSummary page 2…heir own nebulizers, Fasterjet and Nebjet, are substantially equivalent to a combination of the following devices: / Healthdyne, Inc - NEBULIZER SYSTEM - K922623 V Invacare - PRO, COMPACT and PORTABLE DESKTOP - K042483 · Salter Labs - Salter Aire Compressor - K99… | 1992 |
| * | K042483 | Invacare Pro, Compact and Portable DesktopSummary page 2…valent to a combination of the following devices: / Healthdyne, Inc - NEBULIZER SYSTEM - K922623 V Invacare - PRO, COMPACT and PORTABLE DESKTOP - K042483 · Salter Labs - Salter Aire Compressor - K992285 V Medical Industries Sport-Neb (K964078) for… | 2005 |
| * | K992285 | Salter Aire CompressorSummary page 2…ealthdyne, Inc - NEBULIZER SYSTEM - K922623 V Invacare - PRO, COMPACT and PORTABLE DESKTOP - K042483 · Salter Labs - Salter Aire Compressor - K992285 V Medical Industries Sport-Neb (K964078) for compressors, and V Salter Labs 8900 nebulizer - K870… | 2000 |
| * | K964078 | 3050 Sport-NebSummary page 2…V Invacare - PRO, COMPACT and PORTABLE DESKTOP - K042483 · Salter Labs - Salter Aire Compressor - K992285 V Medical Industries Sport-Neb (K964078) for compressors, and V Salter Labs 8900 nebulizer - K870027 V Medic-Aid Sidestream Nebulizer - K991… | 1997 |
| * | K870027 | Hand Held Pheumatic Powered (Disposable) NebulizerSummary page 2…lter Labs - Salter Aire Compressor - K992285 V Medical Industries Sport-Neb (K964078) for compressors, and V Salter Labs 8900 nebulizer - K870027 V Medic-Aid Sidestream Nebulizer - K991725 V Pari LC STAR nebulizer - K963924 for nebulizers. 4.… | 1987 |
| * | K991725 | Sidestream NebulizerSummary page 2…V Medical Industries Sport-Neb (K964078) for compressors, and V Salter Labs 8900 nebulizer - K870027 V Medic-Aid Sidestream Nebulizer - K991725 V Pari LC STAR nebulizer - K963924 for nebulizers. 4. Device Description The family of 3A Health Care… | 1999 |
| * | K963924 | LC Star Reusable Nebulizer 22F50 and LC Star Disposable Nebulizer 22F70Summary page 2…for compressors, and V Salter Labs 8900 nebulizer - K870027 V Medic-Aid Sidestream Nebulizer - K991725 V Pari LC STAR nebulizer - K963924 for nebulizers. 4. Device Description The family of 3A Health Care nebulizers include 5 different devices; 4 are… | 1996 |
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 16 years and passes through 4 companies; a new generation was cleared every 3.2 years on median.
- 1 of the 14 ancestors has a recall of any class.
- 2 other devices also cite its predicate K922623.
How does its category compare?
All CAF devicesCAF Nebulizer (Direct Patient Interface): FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 intended use of the Happyneb II, Happyneb III, Speedy, Nebby Plus and the Myneb 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. Each of these devices must be used exclusively with their own nebulizer and mouthpiece. The devices Happyneb II, Happyneb III, Speedy, and the Nebby Plus are intended to be used primarily by patients in the…
Read the full statement (134 words)
The intended use of the Happyneb II, Happyneb III, Speedy, Nebby Plus and the Myneb 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. Each of these devices must be used exclusively with their own nebulizer and mouthpiece.
The devices Happyneb II, Happyneb III, Speedy, and the Nebby Plus are intended to be used primarily by patients in the home care market, although they may also be used by trained hospital staff personnel as well. The Myneb model is intended to be used only in home health care.
The Happyneb II, Happyneb III, Speedy, Nebby Plus and the Myneb are intended for multiple use, are non-sterile and for use with pharmaceutical products which are under physician prescription.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072163 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072163: Happyneb II, Happyneb Iii, Speedy, Nebby Plus and Myneb, Model 5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072163
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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