# K121457: Speedicath Compact Set (12 FR)

- Pathway: 510(k) (Traditional)
- Applicant: Coloplast Corp.
- Decided: Oct 2, 2012 after 139 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.
4 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072808: Speedicath Compact, Coloplast Corp. (2007) Summary page 2.

## Most influential descendants
- K151772: Actreen Mini Intermittent Urinary Catheters (2016), 2 descendants of its own
- K180801: Actreen Hi-Lite Cath, Actreen Hi-Lite Set (2018), 1 descendant of its own
- K192904: SpeediCath Compact Set (2020), 0 descendants of its own
- K192577: Actreen Hi-Lite Intermittent Urinary Catheters (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 females only.

Source page: https://510kreport.com/device/K121457
Methodology: https://510kreport.com/methodology