# K013276: All-Silicone Foley Balloon Catheter (Two Way; Three Way, Radiopaque)

- Pathway: 510(k) (Traditional)
- Applicant: Sewoon Medical Co., Ltd.
- Decided: Feb 15, 2002 after 137 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: 2 generations back to K896053 (1990). 2 ancestors in all.
2 later devices descend 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)
- K981612: All Silicone Foley Catheter, Two-Way Foley Catheter, Three-Way Foley Catheter, Two-Way Radiopaque Foley Catheter, Rochester Medical Corp. (1998) Summary page 1.

## Most influential descendants
- K091767: 3 Way Silicone Foley Balloon Catheter (2009), 1 descendant of its own
- K181616: PSM 3-Way Silicone Foley Catheter (2018), 0 descendants of its own

## Indications for use
For urological use only. Two-Way Catheter: Urethral catheterization for bladder drainage. Three -Way Catheter: Urethral catheterization for bladder drainage and bladder irrigation. Radiopaque Catheter: Urethral catheterization for bladder drainage with radiopaque substance for radiographic visualization

Source page: https://510kreport.com/device/K013276
Methodology: https://510kreport.com/methodology