510(k) · Cleared
ClearedMC 300* Nebulizer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Trudell Medical International · CAF Nebulizer (Direct Patient Interface)
Cleared on Feb 28, 2018 as substantially equivalent to K926055 (Warren C. Miller, 1993) after a 125-day review. Its family tree reaches back 1 generation to 1993. 2 later devices descend from it.
- Decided
- Feb 28, 2018
- Review
- 125 days
- Class
- Class II
- Product code
- CAF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K926055 (1993). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK926055 The Miller Nebulizer SystemWarren C. Miller · 1993
- This deviceK173367 MC 300* NebulizerTrudell Medical International · 2018
- Descendant · cites it directly · 0 of its ownK230602 Hudson RCI® TurboMist™ Nebulizer SystemMedline Industries, LP · 2023
- Descendant · cites it directly · 0 of its ownK203400 Corrugated tube with mouthpiece accessoryTrudell Medical International · 2021
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K926055 | The Miller Nebulizer System | Warren C. Miller | 1993 | — |
| 0 (this device) | K173367 | MC 300* Nebulizer | Trudell Medical International | 2018 | — |
| +1 | K230602 | Hudson RCI® TurboMist™ Nebulizer System | Medline Industries, LP | 2023 | — |
| +1 | K203400 | Corrugated tube with mouthpiece accessory | Trudell Medical International | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2023 | 1 | 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 |
|---|---|---|---|
| * | K926055 | The Miller Nebulizer SystemSummary page 4…Nebulizer 21 CFR 868.5630 Regulatory Class: II Product Code: CAF 3. Predicate Device VixOneTM Nebulizer, K926055 Westmed, Inc. The predicate device has not been subject to a recall. Reference Device AeroEclipse* II Breath… | 1993 |
| † | K053605 | Aeroeclipse II Breath Actuated Nebulizer | 2006 |
What descends from it? (2)
2 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?
How does its category compare?
All CAF devicesCAF Nebulizer (Direct Patient Interface): FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 nebulizer is intended to be used with pediatric (ages 2 years and above) and adult patients, who are under the care of a licensed healthcare provider or physician. The device is designed to aerosolize prescribed medication for inhalation by a patient in the hospital, clinic or home care environment. The nebulizer is a single patient use device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173367 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173367: MC 300* Nebulizer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173367
Report an extraction error
Are you the manufacturer?
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