# K223821: Self-Cath Closed System

- Pathway: 510(k) (Traditional)
- Applicant: Coloplast
- Decided: Aug 2, 2023 after 224 days
- Product code: FCM (Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit))
- 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: 3 generations back to K003784 (2001). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221401: Self-Cath and Self-Cath Plus, Coloplast (2022) Summary page 4.

## Indications for use
Self-Cath Closed System is intended for use in male and female adult patients requiring bladder drainage as determined by their physician. The device is indicated for 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/K223821
Methodology: https://510kreport.com/methodology