# K972778: Dey Vial Sodium Chloride 3%

- Pathway: 510(k) (Traditional)
- Applicant: Dey Laboratories, Inc.
- Decided: Oct 8, 1997 after 75 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
Longest line of descent: 1 generation back to K841988 (1984). 3 ancestors in all.
6 later devices descend from it; 3 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K880411: Dey-Vial Sodium Chloride Solution, Usp, Sterile, Dey Laboratories, Inc. (1988) Summary page 1.
- K841988: Arm-a-Vial LV Sodium, Chloride Inhalat, Armour Pharmaceutical Co. (1984) Summary page 1.
- K841989: Arm-a-Vial LV Sodium Chloride Inhalat, Armour Pharmaceutical Co. (1984) Summary page 1.
- (no number) Dis-Pos-Vial: named in the summary without a submission number
- (no number) Redipak: named in the summary without a submission number

## Cited in the summary but kept off the family tree
- K841988-A: Arm-A-Vial. Number could not be read Summary page 1.
- K841989-A: Arm-A-Vial. Number could not be read Summary page 1.

## Most influential descendants
- 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
- K130091: Pulmosal (2013), 0 descendants of its own

## Indications for use
Dey Vial Sodium Chloride 3% and 10% are used in conjunction with a nebulizer for the induction of sputum production where specimen collection is indicated.

Source page: https://510kreport.com/device/K972778
Methodology: https://510kreport.com/methodology