510(k) · Cleared
ClearedDey-Vial Sodium Chloride Solution, Usp, Sterile
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dey Laboratories, Inc. · CAF Nebulizer (Direct Patient Interface)
Cleared on Feb 29, 1988 after a 28-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 7 later devices descend from it.
- Decided
- Feb 29, 1988
- Review
- 28 days
- Class
- Class II
- Product code
- CAF
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 1 citing it directly.
- This deviceK880411 Dey-Vial Sodium Chloride Solution, Usp, SterileDey Laboratories, Inc. · 1988
- Descendant · cites it directly · 6 of its ownK972778 Dey Vial Sodium Chloride 3%Dey Laboratories, Inc. · 1997
- Descendant · 2 generations on · 5 of its ownK070498 Hyper SalPari Innovative Manufacturers, Inc. · 2007
- Descendant · 2 generations on · 4 of its ownK101424 Pharmacaribe Inhaled Saline SolutionsPharmacaribe · 2010
- Descendant · 3 generations on · 0 of its ownK232523 Sodium Chloride Inhalation Solution, USP 0.9%, 3% & 7%Mankind Pharma Limited · 2024
- Descendant · 3 generations on · 0 of its ownK210126 Sodium Chloride Inhalation Solutions, 3%, 3.5%, 7% and 10%The Ritedose Corporation · 2021
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K972778Dey Vial Sodium Chloride 3%Dey Laboratories, Inc. · 1997 · cites it directly6descendants
- K070498Hyper SalPari Innovative Manufacturers, Inc. · 2007 · 2 generations on5descendants
- K101424Pharmacaribe Inhaled Saline SolutionsPharmacaribe · 2010 · 2 generations on4descendants
- K232523Sodium Chloride Inhalation Solution, USP 0.9%, 3% & 7%Mankind Pharma Limited · 2024 · 3 generations on0descendants
- K210126Sodium Chloride Inhalation Solutions, 3%, 3.5%, 7% and 10%The Ritedose Corporation · 2021 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K880411 | Dey-Vial Sodium Chloride Solution, Usp, Sterile | Dey Laboratories, Inc. | 1988 | — |
| +1 | K972778 | Dey Vial Sodium Chloride 3% | Dey Laboratories, Inc. | 1997 | — |
| +2 | K070498 | Hyper Sal | Pari Innovative Manufacturers, Inc. | 2007 | — |
| +2 | K101424 | Pharmacaribe Inhaled Saline Solutions | Pharmacaribe | 2010 | — |
| +3 | K232523 | Sodium Chloride Inhalation Solution, USP 0.9%, 3% & 7% | Mankind Pharma Limited | 2024 | — |
| +3 | K210126 | Sodium Chloride Inhalation Solutions, 3%, 3.5%, 7% and 10% | The Ritedose Corporation | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K972778 | Dey Vial Sodium Chloride 3% | 1997 | 6 |
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, K972778 (Dey Laboratories, Inc., 1997) has gone furthest, with 6 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/K880411 · printed Nov 5, 2026
Cite this page
510(k) Report. “K880411: Dey-Vial Sodium Chloride Solution, Usp, Sterile.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K880411
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026