# K072808: Speedicath Compact

- Pathway: 510(k) (Traditional)
- Applicant: Coloplast Corp.
- Decided: Nov 9, 2007 after 39 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.
12 later devices descend from it; 5 cite it directly.
0 of 18 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
- K121457: Speedicath Compact Set (12 FR) (2012), 4 descendants of its own
- K203637: SpeediCath Compact (28578, 28580, 28582, 28584), SpeediCath Compact Plus (28810, 28812, 28814) (2022), 2 descendants of its own
- K151772: Actreen Mini Intermittent Urinary Catheters (2016), 2 descendants of its own
- K122785: Hydrosil; Magic; Personal Catheter (2013), 2 descendants of its own
- K180801: Actreen Hi-Lite Cath, Actreen Hi-Lite Set (2018), 1 descendant of its own

## Indications for use
SpeediCath Compact 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 catheter is for female patients only.

Source page: https://510kreport.com/device/K072808
Methodology: https://510kreport.com/methodology