# K233094: Wellead® Latex Foley Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Well Lead Medical (Hainan) Co., Ltd.
- Decided: Jun 6, 2024 after 254 days
- Product code: MJC (Catheter, Urological (Antimicrobial) And Accessories)
- 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). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082815: Well Lead Silicone and Latex Foley Catheters, Well Lead Medical Instruments (2008) Summary page 5.

## Most influential descendants
- K243011: Silicone Urethral Catheter (Silicone Urethral Catheter) (2025), 0 descendants of its own

## Indications for use
Latex Foley Catheter is inserted into the bladder through urethra and are indicated for routine urine drainage or for routine post-operative drainage and bladder irrigation.

Source page: https://510kreport.com/device/K233094
Methodology: https://510kreport.com/methodology