# K101424: Pharmacaribe Inhaled Saline Solutions

- Pathway: 510(k) (Traditional)
- Applicant: Pharmacaribe
- Decided: Aug 17, 2010 after 89 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: 3 generations back to K841988 (1984). 5 ancestors in all.
4 later devices descend from it; 4 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)
- K972778: Dey Vial Sodium Chloride 3%, Dey Laboratories, Inc. (1997) Summary page 1.
- K070498: Hyper Sal, Pari Innovative Manufacturers, Inc. (2007) Summary page 1.

## Most influential descendants
- 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
- K120051: Sodium Chloride Inhalation Solution, 3%, 7%, and 10%, Usp-4ML (2012), 0 descendants of its own

## Indications for use
PharmaCaribe inhaled saline solutions are used in conjunction with a nebulizer. The contents of these vials are for the induction of sputum production where sputum production is indicated. Concentrations of 3%, 3.5%, 6%, 7%, and 10%

Source page: https://510kreport.com/device/K101424
Methodology: https://510kreport.com/methodology