# K980829: 3ML Steri-Neb Saline - 0.9% W/V Sodium Chloride Inhalation Solution Usp

- Pathway: 510(k) (Traditional)
- Applicant: Steripak, Ltd.
- Decided: Jun 2, 1998 after 90 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: 1 generation back to K840943 (1984). 1 ancestor in all.
4 later devices descend from it; 1 cites it directly.
1 of 6 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K840943: Endo-Ject, Autovage (1984) Summary page 1.

## Most influential descendants
- 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
- K231058: Hudson RCI® AddiPak® Unit Dose Vial (2024), 0 descendants of its own
- K130091: Pulmosal (2013), 0 descendants of its own

## Indications for use
For respiratory therapy and tracheal lavage

Source page: https://510kreport.com/device/K980829
Methodology: https://510kreport.com/methodology