# K130091: Pulmosal

- Pathway: 510(k) (Special)
- Applicant: Pharmacaribe
- Decided: Mar 13, 2013 after 57 days
- Product code: CAF (Nebulizer (Direct Patient Interface))
- Device class: 2
- Regulation: 21 CFR 868.5630
- Recalls of this device: 1 (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). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 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 1.
- K113033: Sodium Chlorde Inhalation Solution, 0.9% Usp-3ML, Nephron Pharmaceuticals Corp. (2012) Summary page 3.

## Recalls of this device
- Dec 29, 2015 · Class II · Z-0795-2016: Vials were labeled as USP 7% Hypertonic saline instead of PulmoSal 7% (pH+)

## 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 0.9%, 3%, 3.5%, 6%, 7%, and 10% with a pH of 7.4

Source page: https://510kreport.com/device/K130091
Methodology: https://510kreport.com/methodology