# K972466: Sodium Chloride Inhalation Solution, Usp

- Pathway: 510(k) (Traditional)
- Applicant: Holopack International, LP
- Decided: Aug 28, 1997 after 58 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 K870332 (1987). 2 ancestors in all.
5 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)
- K884359: Unit Dose 3% Sodium Chloride Solution for Inhala., Automatic Liquid Packaging, Inc. (1988) Summary page 3.
- K870332: Prefilled Respiratory Therapy Vials, Automatic Liquid Packaging, Inc. (1987) Summary page 3.
- (no number) Respiratory Therapy Vials — Travenol Laboratories; Wyeth Laboratories, Inc.: named in the summary without a submission number
- (no number) Sodium Chloride Solution for Inhalation — Dey Laboratories, Inc.: named in the summary without a submission number

## 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
- 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
- K130091: Pulmosal (2013), 0 descendants of its own

## Indications for use
The intended use of these sterile single use devices is as accessories to medicinal non-ventilatory nebulizers in respiratory therapy or for tracheal irrigation or lavage.

Source page: https://510kreport.com/device/K972466
Methodology: https://510kreport.com/methodology