# K202134: Well Lead All Silicone Foley Catheter with Temperature Sensor

- Pathway: 510(k) (Special)
- Applicant: Well Lead Medical Co., Ltd.
- Decided: Apr 8, 2021 after 251 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: 4 generations back to K896053 (1990). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091516: Well Lead Silicone Catheter with Temperature Sensor, Well Lead Medical Co., Ltd. (2009) Summary page 5.

## Indications for use
All Silicone Foley Catheter With Temperature Sensor is intended for use in the drainage/collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgical or post-surgical intervals.

Source page: https://510kreport.com/device/K202134
Methodology: https://510kreport.com/methodology