# K974759: Hydrox Saline Solution 0.9% Sodium Chloride 4 OZ. Cup 120 ML 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
Longest line of descent: 1 generation back to K943834 (1994). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K943834: Sterile .9% Sodium Chloride Solution, Orion Life Systems, Inc. (1994) Summary page 3.
- (no number) Kit Pak Sterile 0.9% Sodium Chloride Solution: named in the summary without a submission number

## Indications for use
Not for injection, for suction catheter procedures. Hydrox Sterile Saline 0.9% Sodium Chloride Solution 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 0.9% Sodium Chloride Solution K943834 and Kit Pak Sterile 0.9% Sodium Chloride Solution (number unknown).

Source page: https://510kreport.com/device/K974759
Methodology: https://510kreport.com/methodology