# K210250: SpeedCath Compact Male

- Pathway: 510(k) (Traditional)
- Applicant: Coloplast
- Decided: Apr 26, 2022 after 452 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: 5 generations back to K910022 (1991). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143182: Speedicath Compact Male, Coloplast A/S (2015) Summary page 4.

## Indications for use
The catheter is indicated for use by patients with chronic urine retention and patients with a post void residual volume (PVR) due to neurogenic and non-neurogenic voiding dysfunction. The catheter is inserted into the urethra to reach the bladder allowing the urine to drain. The catheter is intended for males only.

Source page: https://510kreport.com/device/K210250
Methodology: https://510kreport.com/methodology