510(k) · Cleared
ClearedComp a-I-R
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 Sep 2, 2011 as substantially equivalent to K060811 (Omron Healthcare, Inc., 2006) after a 157-day review. Its family tree reaches back 2 generations to 1992. 3 later devices descend from it.
- Decided
- Sep 2, 2011
- Review
- 157 days
- Class
- Class II
- Product code
- CAF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K914836 (1992). 3 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK914836 Omron Compressor Nebulizer- Model NE-C09Omron Healthcare, Inc. · 1992
- 1 generation backK060811 Omron Compressor Systems, Models NE-C28,NE-C30Omron Healthcare, Inc. · 2006
- This deviceK110860 Comp a-I-ROmron Healthcare, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK243244 Heated Breathing TubeGuangdong Eda Technology Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK243468 Compressor Nebulizer (NB-1100); Compressor Nebulizer (NB-1101)…Joytech Healthcare Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK141140 Comp a-I-ROmron Healthcare, Inc. · 2014
Most influential descendants
Showing 3 of 3 · See all- K243244Heated Breathing TubeGuangdong Eda Technology Co., Ltd. · 2025 · cites it directly0descendants
- K243468Compressor Nebulizer (NB-1100); Compressor Nebulizer (NB-1101); Compressor Nebulizer…Joytech Healthcare Co., Ltd. · 2025 · cites it directly0descendants
- K141140Comp a-I-ROmron Healthcare, Inc. · 2014 · cites it directly0descendants
View 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 | K060811 | Omron Compressor Systems, Models NE-C28,NE-C30 | Omron Healthcare, Inc. | 2006 | — |
| 0 (this device) | K110860 | Comp a-I-R | Omron Healthcare, Inc. | 2011 | — |
| +1 | K243244 | Heated Breathing Tube | Guangdong Eda Technology Co., Ltd. | 2025 | — |
| +1 | K243468 | Compressor Nebulizer (NB-1100); Compressor Nebulizer (NB-1101); Compressor… | Joytech Healthcare Co., Ltd. | 2025 | — |
| +1 | K141140 | Comp a-I-R | Omron Healthcare, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K060811 | Omron Compressor Systems, Models NE-C28,NE-C30Summary page 1…integral compressor and handheld, pneumatic nebulizer intended for general purpose use. It is powered by standard AC. This is a modification of the NE-C28 cleared under K06081 11. The modifications to the device do not change the intended use of the predicate device. The modifications to the device do not… | 2006 |
What descends from it? (3)
3 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 19 years and passes through 1 company; a new generation was cleared every 14.1 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K243244 (Guangdong Eda Technology Co., Ltd., 2025) 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. 2011, 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 NE-C801 Nebulizer Compressor System is intended to provide air to the pneumatic nebulizer in order to aerosolize medications for inhalation by the patient for respiratory disorders. The system is designed for use with pediatric (defined by the prescribed medication) and adult patients in the home, hospital, and sub-acute settings.
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/K110860 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110860: Comp a-I-R.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110860
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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