# K974397: Sterile Saline for Catheter Care

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corp
- Decided: Feb 10, 1998 after 81 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. The FDA summary names its predicate without a number.
- (no number) Current Baxter Respiratory Therapy Solutions: named in the summary without a submission number

## Indications for use
Baxter Sterile Saline for Catheter Care is indicated for flushing or cleaning urinary drainage and suction catheters.

Source page: https://510kreport.com/device/K974397
Methodology: https://510kreport.com/methodology