# K143182: Speedicath Compact Male

- Pathway: 510(k) (Traditional)
- Applicant: Coloplast A/S
- Decided: Jan 20, 2015 after 76 days
- Product code: GBM (Catheter, Urethral)
- 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: 4 generations back to K910022 (1991). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121458: Speedicath Compact Set (12/18 FR), Coloplast A/S (2012) Summary page 5.

## Most influential descendants
- K210250: SpeedCath Compact Male (2022), 0 descendants of its own

## Indications for use
SpeediCath Compact Male is indicated for use by patients with 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 urine to drain. The catheter is for male patients.

Source page: https://510kreport.com/device/K143182
Methodology: https://510kreport.com/methodology