# K113033: Sodium Chlorde Inhalation Solution, 0.9% Usp-3ML

- Pathway: 510(k) (Traditional)
- Applicant: Nephron Pharmaceuticals Corp.
- Decided: Jun 19, 2012 after 251 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: 2 generations back to K870332 (1987). 5 ancestors in all.
3 later devices descend from it; 2 cite it directly.
1 of 9 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972466: Sodium Chloride Inhalation Solution, Usp, Holopack International, LP (1997) Summary page 1.
- K980829: 3ML Steri-Neb Saline - 0.9% W/V Sodium Chloride Inhalation Solution Usp, Steripak, Ltd. (1998) Summary page 1.

## Most influential descendants
- K142153: Hudson Rci Addipak Unit Dose Vial, 0.9% Full Normal Saline Solution, 3ML;5ML;15ML (2015), 1 descendant of its own
- K231058: Hudson RCI® AddiPak® Unit Dose Vial (2024), 0 descendants of its own
- K130091: Pulmosal (2013), 0 descendants of its own

## Indications for use
This sterile, single-use device is intended to be used as an accessory to medicinal non-ventilatory nebulizers for respiratory therapy or for tracheal irrigation or lavage therapy. This device is not intended for parenteral use or for preparations intended for parenteral use.

Source page: https://510kreport.com/device/K113033
Methodology: https://510kreport.com/methodology