# K172807: Silicone Foley Catheter for single use

- Pathway: 510(k) (Traditional)
- Applicant: Changzhou Rongxin Medicine Minimal Invasion Technology
- Decided: Jun 4, 2018 after 259 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: 3 generations back to K896053 (1990). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130908: Disposable Silicone Foley Catheter, Guangdong Baihe Medical Technology Co., Ltd. (2013) Summary page 6.

## Indications for use
Two-way Disposable Silicone Foley Catheter: Urethral catheterization for bladder drainage and urological use only; the indwelling time 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 indwelling time is no more than 30 days.

Source page: https://510kreport.com/device/K172807
Methodology: https://510kreport.com/methodology