# K130908: Disposable Silicone Foley Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Guangdong Baihe Medical Technology Co., Ltd.
- Decided: Oct 3, 2013 after 185 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.
6 later devices descend from it; 6 cite it directly.
0 of 9 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 2.

## Most influential descendants
- K201776: Foley Balloon Catheter for Urology (2020), 0 descendants of its own
- K182463: Silicone Foley Catheter (2019), 0 descendants of its own
- K172807: Silicone Foley Catheter for single use (2018), 0 descendants of its own
- K172278: Firlit-Kluge Urethral Stent, Koyle Diaper Stent, Zaontz Urethral Stent (2017), 0 descendants of its own
- K170233: Diposable Urinary Catheter (PVC Urinary Catheter, Silicone Urinary Catheter, Latex Urinary Catheter) (2017), 0 descendants of its own

## Indications for use
Two-way Disposable Silicone Foley Catheter Urethral catheterization for bladder drainage for urological use only; the indwell time of the proposed device is no more than 30 days. Three-way Disposable Silicone Foley Catheter Urethral catheterization for bladder drainage and bladder irrigation for urological use only; the indwell time of the proposed device is no more than 30 days.

Source page: https://510kreport.com/device/K130908
Methodology: https://510kreport.com/methodology