# K972467: Sterile Water for Inhalation, 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). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K871618: Prefilled Sterile Water for Inhalation, Usp, Automatic Liquid Packaging, Inc. (1987) Summary page 3.
- K870332: Prefilled Respiratory Therapy Vials, Automatic Liquid Packaging, Inc. (1987) Summary page 3.
- K881184: Intertech Sterile Water for Inhalation, Delmed, Inc. (1988) Summary page 3.
- (no number) Sterile Water for Inhalation, USP — Dey Laboratories, Inc.: 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/K972467
Methodology: https://510kreport.com/methodology