# K050008: Mentor Self-Cath Hydrogel Intermittent Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Mentor Corp.
- Decided: Jun 3, 2005 after 151 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
Longest line of descent: 1 generation back to K003873 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003873: Mentor Self-Cath Closed System, Mentor Corp. (2001) Summary page 2.

## Cited in the summary but kept off the family tree
- K003874: CBC-4K Hematology Control, R&D Systems, Inc. (2001). Our reading of the summary gave K003874, FDA’s number for CBC-4K Hematology Control (R&D Systems, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Mentor Self-Cath Plus Catheter”. Kept off the family tree. Summary page 2.

## Indications for use
The Mentor Self-Cath® HydroGel TM Intermittent Urethral Urinary Catheter is intended for use in male, female and pediatric patients requiring bladder drainage as determined by their physician. This device is indicated for those individuals who are unable to promote a natural urine flow or for those individuals who have a significant volume of residual urine following a natural bladder-voiding episode

Source page: https://510kreport.com/device/K050008
Methodology: https://510kreport.com/methodology