510(k) · Cleared
ClearedThe Miller Nebulizer System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Warren C. Miller · CAF Nebulizer (Direct Patient Interface)
Cleared on Feb 3, 1993 after a 90-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 6 later devices descend from it.
- Decided
- Feb 3, 1993
- Review
- 90 days
- Class
- Class II
- Product code
- CAF
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 4 citing it directly.
- This deviceK926055 The Miller Nebulizer SystemWarren C. Miller · 1993
- Descendant · cites it directly · 2 of its ownK173367 MC 300* NebulizerTrudell Medical International · 2018
- Descendant · 2 generations on · 0 of its ownK230602 Hudson RCI® TurboMist™ Nebulizer SystemMedline Industries, LP · 2023
- Descendant · 2 generations on · 0 of its ownK203400 Corrugated tube with mouthpiece accessoryTrudell Medical International · 2021
- Descendant · cites it directly · 0 of its ownK140237 Disposable Nebulizer SetSuzhou Weikang Medical Apparatus Co., Ltd. · 2015
- Descendant · cites it directly · 0 of its ownK112041 Koo Small Volume Nebulizer (SVN)Koo (Shanghai) Industries Co., Ltd. · 2011
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K173367MC 300* NebulizerTrudell Medical International · 2018 · cites it directly2descendants
- K230602Hudson RCI® TurboMist™ Nebulizer SystemMedline Industries, LP · 2023 · 2 generations on0descendants
- K203400Corrugated tube with mouthpiece accessoryTrudell Medical International · 2021 · 2 generations on0descendants
- K140237Disposable Nebulizer SetSuzhou Weikang Medical Apparatus Co., Ltd. · 2015 · cites it directly0descendants
- K112041Koo Small Volume Nebulizer (SVN)Koo (Shanghai) Industries Co., Ltd. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K926055 | The Miller Nebulizer System | Warren C. Miller | 1993 | — |
| +1 | K173367 | MC 300* Nebulizer | Trudell Medical International | 2018 | — |
| +2 | K230602 | Hudson RCI® TurboMist™ Nebulizer System | Medline Industries, LP | 2023 | — |
| +2 | K203400 | Corrugated tube with mouthpiece accessory | Trudell Medical International | 2021 | — |
| +1 | K140237 | Disposable Nebulizer Set | Suzhou Weikang Medical Apparatus Co., Ltd. | 2015 | — |
| +1 | K112041 | Koo Small Volume Nebulizer (SVN) | Koo (Shanghai) Industries Co., Ltd. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 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? (6)
4 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, K173367 (Trudell Medical International, 2018) has gone furthest, with 2 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/K926055 · printed Nov 6, 2026
Cite this page
510(k) Report. “K926055: The Miller Nebulizer System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K926055
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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