# K142563: Well Lead PVC Urethral Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Well Lead Medical Co., Ltd.
- Decided: Oct 28, 2014 after 47 days
- Product code: EZD (Catheter, Straight)
- 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: 5 generations back to K910022 (1991). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100302: Medline PVC Urethral Catheter, Medline Industries, Inc. (2010) Summary page 4.
- K133615: Well Lead PVC Hydrophilic Urethral Catheter, Well Lead Medical Co., Ltd. (2014) Summary page 4.

## Indications for use
The Well Lead PVC Urethral Catheter is launched for clean intermittent catheterization(CIC) treatment. It is intended for use in the drainage of fluid from the urinary tract.

Source page: https://510kreport.com/device/K142563
Methodology: https://510kreport.com/methodology