510(k) · Cleared
ClearedSmall Volume Nebulizer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Allegiance Healthcare Corporation · CAF Nebulizer (Direct Patient Interface)
Cleared on May 1, 2003 after a 185-day review. The FDA summary names its predicate without a number. 8 later devices descend from it.
- Decided
- May 1, 2003
- Review
- 185 days
- Class
- Class II
- Product code
- CAF
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 4 citing it directly.
- This deviceK023602 Small Volume NebulizerAllegiance Healthcare Corporation · 2003
- Descendant · cites it directly · 3 of its ownK060399 LC Sprint NebulizerPari Innovative Manufacturers, Inc. · 2006
- Descendant · cites it directly · 1 of its ownK123527 AirlifeCare Fusion · 2013
- Descendant · 2 generations on · 0 of its ownK230602 Hudson RCI® TurboMist™ Nebulizer SystemMedline Industries, LP · 2023
- Descendant · 2 generations on · 0 of its ownK092560 Pari SinusPari Respiratory Equipment, Inc. · 2010
- Descendant · cites it directly · 0 of its ownK091794 CARE2 Medical Nebulizer, Model 101/102, 201/202Steve Islava · 2010
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K060399LC Sprint NebulizerPari Innovative Manufacturers, Inc. · 2006 · cites it directly3descendants
- K123527AirlifeCare Fusion · 2013 · cites it directly1descendant
- K230602Hudson RCI® TurboMist™ Nebulizer SystemMedline Industries, LP · 2023 · 2 generations on0descendants
- K092560Pari SinusPari Respiratory Equipment, Inc. · 2010 · 2 generations on0descendants
- K091794CARE2 Medical Nebulizer, Model 101/102, 201/202Steve Islava · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K023602 | Small Volume Nebulizer | Allegiance Healthcare Corporation | 2003 | — |
| +1 | K060399 | LC Sprint Nebulizer | Pari Innovative Manufacturers, Inc. | 2006 | — |
| +1 | K123527 | Airlife | Care Fusion | 2013 | — |
| +2 | K230602 | Hudson RCI® TurboMist™ Nebulizer System | Medline Industries, LP | 2023 | — |
| +2 | K092560 | Pari Sinus | Pari Respiratory Equipment, Inc. | 2010 | — |
| +1 | K091794 | CARE2 Medical Nebulizer, Model 101/102, 201/202 | Steve Islava | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2013 | 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 |
|---|---|---|---|
| * | — | Airlife Misty-Neb Nebulizer Named without a submission number |
What descends from it? (8)
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, K060399 (Pari Innovative Manufacturers, Inc., 2006) has gone furthest, with 3 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 | — |
What is it indicated for?
The Airlife Misty Nebulizer is a pneumatic nebulizer which nebulizes specific drugs for inhalation by a patient. The patient population includes infant, pediatric and adult patients. It's use is indicated whenever a physicidn or healthcare professional administers or prescribes medical aerosol products to a patient using a small volume nebulizer. This product is a single patient use, non-sterile prescriptive device and is designed to be used in either a hospital or homecare environment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023602 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023602: Small Volume Nebulizer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023602
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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