# K133615: Well Lead PVC Hydrophilic Urethral Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Well Lead Medical Co., Ltd.
- Decided: Feb 24, 2014 after 91 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: 4 generations back to K910022 (1991). 9 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062444: HI-Slip and HI-Slip Plus Single Use Hydrophilic Urinary Catheters and Kit, Oasis Medikal Urunler Kimya Sanayi VE Tic A.S. (2007) Summary page 2.

## Most influential descendants
- K220722: PVC Hydrophilic Urethral Catheter (2023), 0 descendants of its own
- K142563: Well Lead PVC Urethral Catheter (2014), 0 descendants of its own

## Indications for use
The Well Lead PVC Hydrophilic Urethral Catheter is launched for clean intermittent catheterization -CIC treatment and indicated for use by patients with chronic urine retention. The catheter is inserted into the bladder through the urethra for emptying the bladder.

Source page: https://510kreport.com/device/K133615
Methodology: https://510kreport.com/methodology