# K062112: Sunmed Foley Catheters

- Pathway: 510(k) (Traditional)
- Applicant: Sunmed, Inc.
- Decided: Jun 4, 2007 after 315 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: 1 generation back to K980870 (1998). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980870: Rusch Silicone Foley Catheter, Rusch, Inc. (1998) Summary page 1.

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

Source page: https://510kreport.com/device/K062112
Methodology: https://510kreport.com/methodology