# K023254: Speedicath

- Pathway: 510(k) (Traditional)
- Applicant: Coloplast Corp.
- Decided: Jan 27, 2003 after 119 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: 2 generations back to K910022 (1991). 4 ancestors in all.
53 later devices descend from it; 7 cite it directly.
0 of 58 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973070: Conveen Easicath Set, Coloplast Corp. (1997) Summary page 1.
- K896750: Lofric (R), Lofric (R) Cath-Kit, Astra Meditec AB (1990) Summary page 1.
- K012374: Modification to: Lofric Plus Single Use Urinary Catheter, Astra Tech, Inc. (2001) Summary page 1.

## Most influential descendants
- K090960: Vapro Intermittent Catheter, Model 72062, 72082,72102, 72122, 72142, 72064, 72084, 72104, 72124,72144, 72164, 72184, (2009), 15 descendants of its own
- K110862: Vapro Plus Intermittent Catheter (2011), 14 descendants of its own
- K141642: Vapro Intermittent Catheter (2014), 13 descendants of its own
- K072808: Speedicath Compact (2007), 12 descendants of its own
- K161672: SpeediCath Flex Coude (2016), 10 descendants of its own

## Indications for use
The SpeediCath 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 urine to drain.

Source page: https://510kreport.com/device/K023254
Methodology: https://510kreport.com/methodology