# K121458: Speedicath Compact Set (12/18 FR)

- Pathway: 510(k) (Traditional)
- Applicant: Coloplast A/S
- Decided: Oct 1, 2012 after 138 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: 3 generations back to K910022 (1991). 5 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023254: Speedicath, Coloplast Corp. (2003) Summary page 2.

## Most influential descendants
- K143182: Speedicath Compact Male (2015), 1 descendant of its own
- K210250: SpeedCath Compact Male (2022), 0 descendants of its own
- K200820: SpeediCath Compact Set (2020), 0 descendants of its own

## Indications for use
Speediath Compact Set 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 urine to drain. The device is intended for males only.

Source page: https://510kreport.com/device/K121458
Methodology: https://510kreport.com/methodology