# K052440: Mentor Self-Cath Hydrogel Intermittent Catheter

- Pathway: 510(k) (Special)
- Applicant: Mentor Corporation
- Decided: Oct 11, 2005 after 35 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 K003874 (2001). 2 ancestors in all.
3 later devices descend 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)
- K003874: CBC-4K Hematology Control, R&D Systems, Inc. (2001) Summary page 2.
- K003873: Mentor Self-Cath Closed System, Mentor Corp. (2001) Summary page 2.

## Most influential descendants
- K071496: Icath, Sterilesure (2007), 2 descendants of its own
- K103043: Colorado Catheter Sterilesure - New Name Perfic Cath (2011), 1 descendant of its own
- K161445: PerfIC Cath Gel S, PerfIC Cath Gel C, PerfIC Cath Hydro S, PerfIC Cath Hydro C (2016), 0 descendants of its own

## Indications for use
The Mentor Self-Cath® HydroGelTM 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/K052440
Methodology: https://510kreport.com/methodology