# K140562: Wijay EZ-Void External Catheter Valve

- Pathway: 510(k) (Traditional)
- Applicant: Leomed, LLC
- Decided: Jun 16, 2014 after 103 days
- Product code: KNY (Accessories, Catheter, G-U)
- 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
The Wijay EZ-Voidm External Catheter Valve Is indicated for use, to aid In emptying the urinary bladder, for short-term (7 days or less) In adult patients with indwelling urethral or Suprapubic catheters and (1) who are capable of operating the device In accordance with its Instructions for use, and (2) for whom normal bladder cycling is not contraindlicated.

Source page: https://510kreport.com/device/K140562
Methodology: https://510kreport.com/methodology