510(k) · Cleared
ClearedOmron Compressor Nebulizer- Model NE-C09
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Omron Healthcare, Inc. · CAF Nebulizer (Direct Patient Interface)
Cleared on May 6, 1992 after a 194-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 12 later devices descend from it.
- Decided
- May 6, 1992
- Review
- 194 days
- Class
- Class II
- Product code
- CAF
- Recalls
- None
- Predicates
- 0
12 later devices descend from it, 4 citing it directly.
- This deviceK914836 Omron Compressor Nebulizer- Model NE-C09Omron Healthcare, Inc. · 1992
- Descendant · cites it directly · 4 of its ownK060811 Omron Compressor Systems, Models NE-C28,NE-C30Omron Healthcare, Inc. · 2006
- Descendant · 2 generations on · 3 of its ownK110860 Comp a-I-ROmron Healthcare, Inc. · 2011
- Descendant · cites it directly · 3 of its ownK032170 Transneb Compressor W/Nebulizer, Model 5000Medical Industries America, Inc. · 2004
- Descendant · 2 generations on · 2 of its ownK042483 Invacare Pro, Compact and Portable DesktopInvacare Corporation · 2005
- Descendant · cites it directly · 1 of its ownK031413 Vigormist Compressor NebulizerVega Technologies, Inc. · 2003 · Recalled
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K060811Omron Compressor Systems, Models NE-C28,NE-C30Omron Healthcare, Inc. · 2006 · cites it directly4descendants
- K110860Comp a-I-ROmron Healthcare, Inc. · 2011 · 2 generations on3descendants
- K032170Transneb Compressor W/Nebulizer, Model 5000Medical Industries America, Inc. · 2004 · cites it directly3descendants
- K042483Invacare Pro, Compact and Portable DesktopInvacare Corporation · 2005 · 2 generations on2descendants
- K031413Vigormist Compressor NebulizerVega Technologies, Inc. · 2003 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K914836 | Omron Compressor Nebulizer- Model NE-C09 | Omron Healthcare, Inc. | 1992 | — |
| +1 | K060811 | Omron Compressor Systems, Models NE-C28,NE-C30 | Omron Healthcare, Inc. | 2006 | — |
| +2 | K110860 | Comp a-I-R | Omron Healthcare, Inc. | 2011 | — |
| +1 | K032170 | Transneb Compressor W/Nebulizer, Model 5000 | Medical Industries America, Inc. | 2004 | — |
| +2 | K042483 | Invacare Pro, Compact and Portable Desktop | Invacare Corporation | 2005 | — |
| +1 | K031413 | Vigormist Compressor Nebulizer | Vega Technologies, Inc. | 2003 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2025 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (12)
See all 124 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?
- Of its descendants, K060811 (Omron Healthcare, Inc., 2006) has gone furthest, with 4 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 | — |
https://510kreport.com/device/K914836 · printed Nov 6, 2026
Cite this page
510(k) Report. “K914836: Omron Compressor Nebulizer- Model NE-C09.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K914836
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026