# K232469: Rüsch Latex Gold Foley Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Teleflexmedical, Inc.
- Decided: Aug 1, 2024 after 352 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
Longest line of descent: 3 generations back to K903777 (1990). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173340: Yikang Latex Foley Catheter, Jiangxi Yikang Medical Instrument Group Co., Ltd. (2018) Summary page 4.

## Most influential descendants
- K262056: Rusch Latex Gold Foley Catheter (2026), 0 descendants of its own

## Indications for use
2 Way Latex Foley Catheters Indicated where routine drainage of the bladder is required either postoperatively or for patients with conditions requiring urine drainage. 3 Way Latex Foley Catheters Indicated where routine drainage of the bladder is required either postoperatively or for patients with conditions requiring urine drainage and for patients requiring bladder irrigation.

Source page: https://510kreport.com/device/K232469
Methodology: https://510kreport.com/methodology