# K880411: Dey-Vial Sodium Chloride Solution, Usp, Sterile

- Pathway: 510(k) (Traditional)
- Applicant: Dey Laboratories, Inc.
- Decided: Feb 29, 1988 after 28 days
- Product code: CAF (Nebulizer (Direct Patient Interface))
- Device class: 2
- Regulation: 21 CFR 868.5630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
7 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K972778: Dey Vial Sodium Chloride 3% (1997), 6 descendants of its own
- K070498: Hyper Sal (2007), 5 descendants of its own
- K101424: Pharmacaribe Inhaled Saline Solutions (2010), 4 descendants of its own
- K232523: Sodium Chloride Inhalation Solution, USP 0.9%, 3% & 7% (2024), 0 descendants of its own
- K210126: Sodium Chloride Inhalation Solutions, 3%, 3.5%, 7% and 10% (2021), 0 descendants of its own

Source page: https://510kreport.com/device/K880411
Methodology: https://510kreport.com/methodology