# K232523: Sodium Chloride Inhalation Solution, USP 0.9%, 3% & 7%

- Pathway: 510(k) (Traditional)
- Applicant: Mankind Pharma Limited
- Decided: Apr 10, 2024 after 236 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: 4 generations back to K841988 (1984). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101424: Pharmacaribe Inhaled Saline Solutions, Pharmacaribe (2010) Summary page 5.
- K972466: Sodium Chloride Inhalation Solution, Usp, Holopack International, LP (1997) Summary page 5.

## Indications for use
Sodium Chloride Inhalation Solution, USP 3% and 7% The Sodium Chloride Inhalation Solution, USP is used in conjunction with a nebulizer. The contents of these vials are for the induction of sputum production where sputum production is indicated. Sodium Chloride Inhalation Solution, USP 0.9% The intended use of this sterile device is as accessories to medicinal non-ventilatory nebulizers in respiratory therapy and for tracheal irrigation or lavage.

Source page: https://510kreport.com/device/K232523
Methodology: https://510kreport.com/methodology