# K221401: Self-Cath and Self-Cath Plus

- Pathway: 510(k) (Traditional)
- Applicant: Coloplast
- Decided: Dec 2, 2022 after 200 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: 2 generations back to K003784 (2001). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100878: Self Cath Catheter, Coloplast Manufacturing Us, LLC (2010) Summary page 5.

## Most influential descendants
- K223821: Self-Cath Closed System (2023), 0 descendants of its own

## Indications for use
Self-Cath and Self-Cath Plus are intended for use in male, female and pediatric patients (neonates, infants, children, adolescents, and transitional adolescents) requiring bladder drainage as determined by their physician. The devices are 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/K221401
Methodology: https://510kreport.com/methodology