# K262056: Rusch Latex Gold Foley Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Teleflex Medical Sdn. Bhd.
- Decided: Aug 5, 2026 after 48 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: 4 generations back to K903777 (1990). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232469: Rüsch Latex Gold Foley Catheter, Teleflexmedical, Inc. (2024) Summary page 5.

## 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. Catheters are indicated for use in male and female adults and pediatric patients with the following pediatric subgroups: Children (2 years old to less than 12 years old), Adolescents (12 years old to less than 18 years old), and Transitional Adolescents (18 years old to less than 22 years old but treated like an adult).

Source page: https://510kreport.com/device/K262056
Methodology: https://510kreport.com/methodology