# K142635: Medline Silicone Foley Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Medline Industries, Inc.
- Decided: Jan 9, 2015 after 114 days
- Product code: EZL (Catheter, Retention Type, Balloon)
- Device class: 2
- Regulation: 21 CFR 876.5130
- Recalls of this device: 1 (0 Class I)
- 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 4.

## Most influential descendants
- K241424: InnoCare Specialty Foley Catheter (2024), 0 descendants of its own

## Recalls of this device
- May 28, 2019 · Class II · Z-2042-2020: Loose silicone particulate was found to be present on the shaft of the silicone catheters.

## Indications for use
Medline silicone Foley catheters are intended to be placed in the bladder. through the urethra, to drain urine into a collection device. Two-way catheters are intended for urological bladder drainage only. Three-way catheters are intended for urological bladder drainage and bladder irrigation.

Source page: https://510kreport.com/device/K142635
Methodology: https://510kreport.com/methodology