# K082815: Well Lead Silicone and Latex Foley Catheters

- Pathway: 510(k) (Traditional)
- Applicant: Well Lead Medical Instruments
- Decided: Oct 8, 2008 after 13 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 K896053 (1990). 3 ancestors in all.
10 later devices descend from it; 6 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981612: All Silicone Foley Catheter, Two-Way Foley Catheter, Three-Way Foley Catheter, Two-Way Radiopaque Foley Catheter, Rochester Medical Corp. (1998) Summary page 2.
- K040658: Bardex I.C. Latex Foley Catheter, C.R. Bard, Inc. (2004) Summary page 2.

## Most influential descendants
- K233094: Wellead® Latex Foley Catheter (2024), 1 descendant of its own
- K142635: Medline Silicone Foley Catheter (2015), 1 descendant of its own
- K091516: Well Lead Silicone Catheter with Temperature Sensor (2009), 1 descendant of its own
- K091767: 3 Way Silicone Foley Balloon Catheter (2009), 1 descendant of its own
- K243011: Silicone Urethral Catheter (Silicone Urethral Catheter) (2025), 0 descendants of its own

## Indications for use
Two - Way Catheters - Urethral catheterization for bladder drainage for urological use only. Three - Way Catheters - Urethral catheterization for bladder drainage and bladder irrigation for urological use only.

Source page: https://510kreport.com/device/K082815
Methodology: https://510kreport.com/methodology