# K201776: Foley Balloon Catheter for Urology

- Pathway: 510(k) (Traditional)
- Applicant: Apollon Co., Ltd.
- Decided: Dec 30, 2020 after 184 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 4.

## Indications for use
Two-way and Three-way Disposable Silicone Foley Catheters are indicated for urethral catheterization for bladder drainage for urological use only. The Two-way and Three-way Disposable Silicone Foley Catheters have an indwell time of no more than 30 days and are indicated for adult use only.

Source page: https://510kreport.com/device/K201776
Methodology: https://510kreport.com/methodology