# K252537: Rusch SoftSimplastic Foley Catheters

- Pathway: 510(k) (Traditional)
- Applicant: Teleflex Medical Sdn. Bhd.
- Decided: Jan 20, 2026 after 161 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: 5 generations back to K984084 (1999). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212077: Teleflex Rusch SoftSimplastic Foley Catheters, Teleflexmedical, Inc. (2023) Summary page 5.

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

Source page: https://510kreport.com/device/K252537
Methodology: https://510kreport.com/methodology