# K140667: Well Lead Hydrophilic Silicone Foley Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Well Lead Medical Co., Ltd.
- Decided: Dec 15, 2014 after 272 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 K984084 (1999). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984084: Bardex Lubri-Sil Foley Catheter, Bard Medical Div. (1999) Summary page 4.
- K002868: Bard All-Silicone 3-Way Foley Catheter; Bard Lubri-Sil 3-Way Foley Catheter; Bard Lubri-Sil I.C. 3-Way Foley Catheter, C.R. Bard, Inc. (2000) Summary page 4.
- K070508: Bardex Lubri-Sil All-Silicone Lubricious Coated Foley Catheter 6 FR, C.R. Bard, Inc. (2007) Summary page 4.

## Indications for use
The Well Lead Hydrophilic Silicone Foley Catheter is intended for use for bladder management including urine drainage, collection and measurement. The Catheter is passed through the urethra during urinary catheterization and into the bladder to drain urine. The Three-way Catheter provides a lumen that is used for bladder irrigation.

Source page: https://510kreport.com/device/K140667
Methodology: https://510kreport.com/methodology