# K120051: Sodium Chloride Inhalation Solution, 3%, 7%, and 10%, Usp-4ML

- Pathway: 510(k) (Traditional)
- Applicant: Nephron Pharmaceuticals Corp.
- Decided: Apr 20, 2012 after 105 days
- Product code: CAF (Nebulizer (Direct Patient Interface))
- Device class: 2
- Regulation: 21 CFR 868.5630
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K841988 (1984). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070498: Hyper Sal, Pari Innovative Manufacturers, Inc. (2007) Summary page 1.
- K101424: Pharmacaribe Inhaled Saline Solutions, Pharmacaribe (2010) Summary page 1.
- K972778: Dey Vial Sodium Chloride 3%, Dey Laboratories, Inc. (1997) Summary page 1.

## Recalls of this device
- Nov 16, 2015 · Class II · Z-2054-2016: Lack of Assurance of Sterility: Internal dye ingress test failure to assure the integrity of the vial.
- Nov 16, 2015 · Class II · Z-2053-2016: Lack of Assurance of Sterility: Internal dye ingress test failure to assure the integrity of the vial.

## Indications for use
To be used in conjunction with a nebulizer, the contents of these vials are for the induction of sputum production where sputum production is indicated.

Source page: https://510kreport.com/device/K120051
Methodology: https://510kreport.com/methodology