510(k) · Cleared
ClearedInvacare Pro, Compact and Portable Desktop
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Invacare Corporation · CAF Nebulizer (Direct Patient Interface)
Cleared on Jan 6, 2005 as substantially equivalent to K980074 (Project Marketing, 1998) and 1 other predicate after a 115-day review. Its family tree reaches back 2 generations to 1992. 2 later devices descend from it.
- Decided
- Jan 6, 2005
- Review
- 115 days
- Class
- Class II
- Product code
- CAF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K914836 (1992). 5 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK914836 Omron Compressor Nebulizer- Model NE-C09Omron Healthcare, Inc. · 1992
- 1 generation backK032170 Transneb Compressor W/Nebulizer, Model 5000Medical Industries America, Inc. · 2004
- This deviceK042483 Invacare Pro, Compact and Portable DesktopInvacare Corporation · 2005
- Descendant · cites it directly · 0 of its ownK072163 Happyneb II, Happyneb Iii, Speedy, Nebby Plus and Myneb, Model 53A Health Care S.R.L. · 2008
- Descendant · cites it directly · 0 of its ownK062014 Families of Master Neb, Primo Neb, SC03, Neb Aid, 4.2.Neb, Q03…Flaem Nuova S.P.A. · 2007
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K914836 | Omron Compressor Nebulizer- Model NE-C09 | Omron Healthcare, Inc. | 1992 | — |
| −1 | K032170 | Transneb Compressor W/Nebulizer, Model 5000 | Medical Industries America, Inc. | 2004 | — |
| 0 (this device) | K042483 | Invacare Pro, Compact and Portable Desktop | Invacare Corporation | 2005 | — |
| +1 | K072163 | Happyneb II, Happyneb Iii, Speedy, Nebby Plus and Myneb, Model 5 | 3A Health Care S.R.L. | 2008 | — |
| +1 | K062014 | Families of Master Neb, Primo Neb, SC03, Neb Aid, 4.2.Neb, Q03, FJ03, and… | Flaem Nuova S.P.A. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 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? (2)
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 |
|---|---|---|---|
| * | K980074 | 56 Series Aerosol GeneratorSummary page 5…e Portable Desktop Common Name: Nebulizer Classification Name: Nebulizer (Direct Patient Interface) Legally Marketed Predicate Device(s): 56 Series Aerosol Generator, K980074, June 12, 1998 Transneb Compressor wlNebulizer, Model 5000, K032 170,… | 1998 |
| * | K032170 | Transneb Compressor W/Nebulizer, Model 5000Summary page 5…ally Marketed Predicate Device(s): 56 Series Aerosol Generator, K980074, June 12, 1998 Transneb Compressor wlNebulizer, Model 5000, K032 170, May 28, 2004 Device Description: Invacare Pro Nebulizer: The Invacare Pro Nebulizer is a… | 2004 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 13 years and passes through 3 companies; a new generation was cleared every 12.1 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K072163 (3A Health Care S.R.L., 2008) has gone furthest, with 0 descendants of its own.
How does its category compare?
All CAF devicesCAF Nebulizer (Direct Patient Interface): FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Invacare Pro Nebulizer and the Invacare Compact Nebulizer 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. The Invacare Pro Nebulizer and Compact Nebulizer are indicated for use with any commercially available nebulizer and mouthpiece. The Invacare Pro Nebulizer and Compact Nebulizer are intended for home health care…
Read the full statement (132 words)
The intended use of the Invacare Pro Nebulizer and the Invacare Compact Nebulizer 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.
The Invacare Pro Nebulizer and Compact Nebulizer are indicated for use with any commercially available nebulizer and mouthpiece.
The Invacare Pro Nebulizer and Compact Nebulizer are intended for home health care use.
The intended use of the Invacare Portable Desktop Nebulizer 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.
The Invacare Portable Desktop Nebulizer is used exclusively with its own nebulizer and mouthpiece.
The Invacare Portable Desktop Nebulizer is intended for home health care use.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K042483 · printed Nov 4, 2026
Cite this page
510(k) Report. “K042483: Invacare Pro, Compact and Portable Desktop.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042483
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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