# K884359: Unit Dose 3% Sodium Chloride Solution for Inhala.

- Pathway: 510(k) (Traditional)
- Applicant: Automatic Liquid Packaging, Inc.
- Decided: Dec 20, 1988 after 64 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
No predicates in its family tree.
7 later devices descend from it; 2 cite it directly.
1 of 8 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K972466: Sodium Chloride Inhalation Solution, Usp (1997), 5 descendants of its own
- K113033: Sodium Chlorde Inhalation Solution, 0.9% Usp-3ML (2012), 3 descendants of its own
- K142153: Hudson Rci Addipak Unit Dose Vial, 0.9% Full Normal Saline Solution, 3ML;5ML;15ML (2015), 1 descendant of its own
- K232523: Sodium Chloride Inhalation Solution, USP 0.9%, 3% & 7% (2024), 0 descendants of its own
- K231058: Hudson RCI® AddiPak® Unit Dose Vial (2024), 0 descendants of its own

Source page: https://510kreport.com/device/K884359
Methodology: https://510kreport.com/methodology