510(k) · Cleared
ClearedAirlife
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Care Fusion · CAF Nebulizer (Direct Patient Interface)
Cleared on Apr 25, 2013 as substantially equivalent to K023602 (Allegiance Healthcare Corporation, 2003) and 1 other predicate after a 160-day review. Its family tree reaches back 2 generations to 1987. 1 later device descends from it.
- Decided
- Apr 25, 2013
- Review
- 160 days
- Class
- Class II
- Product code
- CAF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K870027 (1987). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK870027 Hand Held Pheumatic Powered (Disposable) NebulizerSalter Labs · 1987 · Recalled
- 1 generation backK962879 Salterlabs 8660 Series NebulizerSalter Labs · 1996 · Recalled
- This deviceK123527 AirlifeCare Fusion · 2013
- Descendant · cites it directly · 0 of its ownK230602 Hudson RCI® TurboMist™ Nebulizer SystemMedline Industries, LP · 2023
Most influential descendants
Showing 1 of 1 · See all- K230602Hudson RCI® TurboMist™ Nebulizer SystemMedline Industries, LP · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K870027 | Hand Held Pheumatic Powered (Disposable) Nebulizer | Salter Labs | 1987 | 1 |
| −1 | K962879 | Salterlabs 8660 Series Nebulizer | Salter Labs | 1996 | 1 |
| 0 (this device) | K123527 | Airlife | Care Fusion | 2013 | — |
| +1 | K230602 | Hudson RCI® TurboMist™ Nebulizer System | Medline Industries, LP | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K023602 | Small Volume NebulizerSummary page 1…izer Classification panel 73 Anesthesiology Regulation Class II per 21 CFR §868.5630, Product code CAF Legally marketed device(s) K023602: Airt-ife Misty Max 10 Nebulizer to which equivalence is K962879: NebliTech HDN claimed Device description… | 2003 |
| * | K962879 | Salterlabs 8660 Series NebulizerSummary page 1…Class II per 21 CFR §868.5630, Product code CAF Legally marketed device(s) K023602: Airt-ife Misty Max 10 Nebulizer to which equivalence is K962879: NebliTech HDN claimed Device description Pneumatic jet nebulizer that aerosolizes medication by driving a… | 1996 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K230602 | Hudson RCI® TurboMist™ Nebulizer System | 2023 | 0 |
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 26 years and passes through 2 companies; a new generation was cleared every 16.5 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K230602 (Medline Industries, LP, 2023) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K023602.
How does its category compare?
All CAF devicesCAF Nebulizer (Direct Patient Interface): FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?
This device is intended to be used to aerosolize liquid medication into gases that are delivered directly to the patient for breathing. The patient population includes adults, pediatrics, and infants that are spontaneously breathing. The product is a prescriptive device intended to be used in hospital setting.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123527 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123527: Airlife.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123527
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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