# K974056: 0.9.% Sodium Chloride Inhalation Solution, Usp

- Pathway: 510(k) (Traditional)
- Applicant: Holopack International, LP
- Decided: Jan 21, 1998 after 86 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.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have 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 2.
- K870332: Prefilled Respiratory Therapy Vials, Automatic Liquid Packaging, Inc. (1987) Summary page 2.
- (no number) Travenol Laboratories (pre-1976): named in the summary without a submission number
- (no number) Wyeth Laboratories, Inc. (pre-1976): named in the summary without a submission number
- (no number) Respiratory Therapy Vials Sodium Chloride Inhalation Solution: named in the summary without a submission number

## 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/K974056
Methodology: https://510kreport.com/methodology