# K092250: Medline Red Rubber Urethral Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Medline Industries, Inc.
- Decided: Jan 21, 2010 after 177 days
- Product code: EYB (Catheter, Ureteral, Gastro-Urology)
- Device class: 2
- Regulation: 21 CFR 876.5130
- Recalls of this device: 2 (0 Class I)
- 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.

## Recalls of this device
- May 4, 2026 · Class II · Z-2479-2026: During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances 
- May 4, 2026 · Class II · Z-2492-2026: During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances 

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

Source page: https://510kreport.com/device/K092250
Methodology: https://510kreport.com/methodology