# K974758: Hydrox Sterile Water 4 OZ. Cup 120 ML., Hydrox Sterile Water 100 ML Bottle

- Pathway: 510(k) (Traditional)
- Applicant: Hydrox Laboratories
- Decided: Mar 9, 1998 after 80 days
- Product code: JOL (Catheter And Tip, Suction)
- Device class: 2
- Regulation: 21 CFR 880.6740
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Not for injection, for suction catheter procedures. Hydrox Sterile Water is intended to be used in device lubrication, moistening and flushing. It is not intended for wound irrigation or IV or IM administration and is labeled as such. The intended use of this device is the same as the intended use of similar devices currently in the market. Refer to Orion Sterile Water 943828, Kit Pak Sterile Water K842166 and Medline Industries Sterile Water K825510A.

Source page: https://510kreport.com/device/K974758
Methodology: https://510kreport.com/methodology