# K980870: Rusch Silicone Foley Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Rusch, Inc.
- Decided: Jun 9, 1998 after 97 days
- Product code: EZL (Catheter, Retention Type, Balloon)
- Device class: 2
- Regulation: 21 CFR 876.5130
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices 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) Bardex: named in the summary without a submission number
- (no number) 4 Sure: named in the summary without a submission number

## Most influential descendants
- K212151: FLUME catheter (2021), 1 descendant of its own
- K231101: Flume Catheter (2023), 0 descendants of its own
- K062112: Sunmed Foley Catheters (2007), 0 descendants of its own

## Indications for use
The Riisch Silicone Foley Balloon Catheter is used to drain fluids to and from the urinary tract.

Source page: https://510kreport.com/device/K980870
Methodology: https://510kreport.com/methodology