510(k) · Cleared
ClearedOmron Compressor Systems, Models NE-C28,NE-C30
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 25, 2006 as substantially equivalent to K914836 (Omron Healthcare, Inc., 1992) after a 62-day review. Its family tree reaches back 1 generation to 1992. 4 later devices descend from it.
- Decided
- May 25, 2006
- Review
- 62 days
- Class
- Class II
- Product code
- CAF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K914836 (1992). 4 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK914836 Omron Compressor Nebulizer- Model NE-C09Omron Healthcare, Inc. · 1992
- This deviceK060811 Omron Compressor Systems, Models NE-C28,NE-C30Omron Healthcare, Inc. · 2006
- Descendant · cites it directly · 3 of its ownK110860 Comp a-I-ROmron Healthcare, Inc. · 2011
- Descendant · 2 generations on · 0 of its ownK243244 Heated Breathing TubeGuangdong Eda Technology Co., Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK243468 Compressor Nebulizer (NB-1100); Compressor Nebulizer (NB-1101)…Joytech Healthcare Co., Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK141140 Comp a-I-ROmron Healthcare, Inc. · 2014
Most influential descendants
Showing 4 of 4 · See all- K110860Comp a-I-ROmron Healthcare, Inc. · 2011 · cites it directly3descendants
- K243244Heated Breathing TubeGuangdong Eda Technology Co., Ltd. · 2025 · 2 generations on0descendants
- K243468Compressor Nebulizer (NB-1100); Compressor Nebulizer (NB-1101); Compressor Nebulizer…Joytech Healthcare Co., Ltd. · 2025 · 2 generations on0descendants
- K141140Comp a-I-ROmron Healthcare, Inc. · 2014 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K914836 | Omron Compressor Nebulizer- Model NE-C09 | Omron Healthcare, Inc. | 1992 | — |
| 0 (this device) | K060811 | Omron Compressor Systems, Models NE-C28,NE-C30 | Omron Healthcare, Inc. | 2006 | — |
| +1 | K110860 | Comp a-I-R | Omron Healthcare, Inc. | 2011 | — |
| +2 | K243244 | Heated Breathing Tube | Guangdong Eda Technology Co., Ltd. | 2025 | — |
| +2 | K243468 | Compressor Nebulizer (NB-1100); Compressor Nebulizer (NB-1101); Compressor… | Joytech Healthcare Co., Ltd. | 2025 | — |
| +2 | K141140 | Comp a-I-R | Omron Healthcare, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2025 | 2 | 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? (1)
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 |
|---|---|---|---|
| * | K914836 | Omron Compressor Nebulizer- Model NE-C09Summary page 1…Nebulizer (Direct Patient Interface) Device: Models NE-C28 and NE-C30 Predicate Devices: Omnron - NF-C09 -K914836 IDevice Descrip tin: The Ornron Compressor Systems, model NE-C28 and NF-C30, consist of a nebulizer and AC powered piston-type… | 1992 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K110860 | Comp a-I-R | 2011 | 3 |
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?
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 Omron Compressor Nebulizer Systems include a compressor and nebulizer, Model NE-C28 uses a DC powered compressor and Model NE-C30 can operate with AC/DC power. The electrically powered compressor provides compressed air to the supplied pneumatic nebulizer to aerosolize drugs for inhalation by the patient.
The nebulizer is driven by the integral air compressor. The device may be used with pediatric and adult patients in the home, hospital, and sub-acute care settings.
It is not intended for use with Pentamidine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060811 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060811: Omron Compressor Systems, Models NE-C28,NE-C30.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060811
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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