510(k) · Cleared
ClearedHudson RCI® TurboMist™ Nebulizer System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medline Industries, LP · CAF Nebulizer (Direct Patient Interface)
Cleared on Oct 31, 2023 as substantially equivalent to K123527 (Care Fusion, 2013) and 1 other predicate after a 242-day review. Its family tree reaches back 3 generations to 1987.
- Decided
- Oct 31, 2023
- Review
- 242 days
- Class
- Class II
- Product code
- CAF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K870027 (1987). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK870027 Hand Held Pheumatic Powered (Disposable) NebulizerSalter Labs · 1987 · Recalled
- 2 generations backK962879 Salterlabs 8660 Series NebulizerSalter Labs · 1996 · Recalled
- 1 generation backK123527 AirlifeCare Fusion · 2013
- This deviceK230602 Hudson RCI® TurboMist™ Nebulizer SystemMedline Industries, LP · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K870027 | Hand Held Pheumatic Powered (Disposable) Nebulizer | Salter Labs | 1987 | 1 |
| −2 | K962879 | Salterlabs 8660 Series Nebulizer | Salter Labs | 1996 | 1 |
| −1 | K123527 | Airlife | Care Fusion | 2013 | — |
| 0 (this device) | K230602 | Hudson RCI® TurboMist™ Nebulizer System | Medline Industries, LP | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 2003 | 1 | 0 |
| 2018 | 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? (2)
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 |
|---|---|---|---|
| * | K123527 | AirlifeSummary page 5…e) Product Code: CAF Regulation Number: 868.5630 Classification: Class II Classification Panel: Anesthesiology 510(k) Number: K123527 6. Secondary Predicate Device Trade Name: MC 300* Common Name: Nebulizer (Direct Patient Interface)… | 2013 |
| * | K173367 | MC 300* NebulizerSummary page 5…erface) Product Code: CAF Regulation Number: 868.5630 Classification: Class II Classification Panel: Anesthesiology 510(k) Number: K173367 This submission demonstrates substantial equivalence to the AirLife Small Volume Nebulizer (K123527) and MC 300* (K… | 2018 |
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?
- The line of descent spans 36 years and passes through 3 companies; a new generation was cleared every 10.5 years on median.
- 2 of the 6 ancestors have a recall of any class.
How does its category compare?
All CAF devicesCAF Nebulizer (Direct Patient Interface): FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 Hudson RCI® TurboMist™ Nebulizer is intended to be used to aerosolize liquid medication into gases that are delivered directly to the patient for breathing.Its use is indicated when a licensed healthcare professional prescribes or administers medical aerosol to a patient using a small volume nebulizer.
The patient population includes adult and pediatric (greater than 22 lbs or 10 kg) patients that are spontaneously breathing.
The product is a single patient, multi-use, non-sterile, disposable, prescriptive device intended to be used in a hospital or homecare environment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230602 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230602: Hudson RCI® TurboMist™ 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/K230602
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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