# K100878: Self Cath Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Coloplast Manufacturing Us, LLC
- Decided: May 26, 2010 after 57 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 K003784 (2001). 1 ancestor in all.
13 later devices descend from it; 8 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003784: Mentor Self-Cath Plus, Mentor Corp. (2001) Summary page 1.

## Most influential descendants
- K133470: Bard Ritecath Intermittent Catheter (2014), 3 descendants of its own
- K142575: Bard RiteCath Intermittent Urinary Catheter (2014), 2 descendants of its own
- K140945: Compactcath Intermittent Urinary Catheter (2014), 2 descendants of its own
- K221401: Self-Cath and Self-Cath Plus (2022), 1 descendant of its own
- K160858: CompactCath Intermittent Urinary Catheter (2016), 1 descendant of its own

## Indications for use
The Self Cath® Catheter is intended for use in male, female, and pediatric patients (neonates, infants, children, adolescents, and transitional adolescents) requiring bladder drainage as determined by their physician. This device is indicated for those individuals 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/K100878
Methodology: https://510kreport.com/methodology