# K943834: Sterile .9% Sodium Chloride Solution

- Pathway: 510(k) (Traditional)
- Applicant: Orion Life Systems, Inc.
- Decided: Nov 21, 1994 after 108 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K974759: Hydrox Saline Solution 0.9% Sodium Chloride 4 OZ. Cup 120 ML 100 ML Bottle (1998), 0 descendants of its own

Source page: https://510kreport.com/device/K943834
Methodology: https://510kreport.com/methodology