510(k) · Cleared
ClearedMerits Model N Series Nebulizer Compressors
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Merits Health Products Co., Ltd. · CAF Nebulizer (Direct Patient Interface)
Cleared on Jul 2, 2010 as substantially equivalent to K002468 (San UP S.A., 2001) after a 288-day review. Its family tree reaches back 1 generation to 2001.
- Decided
- Jul 2, 2010
- Review
- 288 days
- Class
- Class II
- Product code
- CAF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K002468 (2001). No later device cites it as a predicate yet.
- Root · 1 generation backK002468 San UP S.a. Nebulizer Compressor, with Disposable Nebulizer, Model…San UP S.A. · 2001
- This deviceK092859 Merits Model N Series Nebulizer CompressorsMerits Health Products Co., Ltd. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K002468 | San UP S.a. Nebulizer Compressor, with Disposable Nebulizer, Model 3050 | San UP S.A. | 2001 | — |
| 0 (this device) | K092859 | Merits Model N Series Nebulizer Compressors | Merits Health Products Co., Ltd. | 2010 | — |
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 |
|---|---|---|---|
| * | K002468 | San UP S.a. Nebulizer Compressor, with Disposable Nebulizer, Model 3050Summary page 1…at is, the Merits Model N Series Nebulizer Compressors are substantially equivalent to the currently marketed SAN UP S.A. Nebulizer Compressor Model: 3050 (K002468). 9.7 Device Description The Merits Model N Series Nebulizer Compressors consist of AC powered piston-type… | 2001 |
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?
- Its one ancestor has no recall.
How does its category compare?
All CAF devicesCAF Nebulizer (Direct Patient Interface): FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 Merits Model N Series Nebulizer Compressors are AC-powered air compressors intended to provide a source of compressed air for medical purposes for use in home health care. These devices are used in conjunction with a pneumatic nebulizers to produce fine aerosol mists of medication for respiratory therapy, for both children and adults suffering from respiratory disorders such as asthma, allergies, etc.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092859 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092859: Merits Model N Series Nebulizer Compressors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092859
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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