# K100302: Medline PVC Urethral Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Medline Industries, Inc.
- Decided: Jul 2, 2010 after 149 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

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

## Indications for use
Medline's urethral catheter is intended for use in the drainage of fluid from the urinary tract.

Source page: https://510kreport.com/device/K100302
Methodology: https://510kreport.com/methodology