# K200142: SpeediCath Soft

- Pathway: 510(k) (Traditional)
- Applicant: Coloplast
- Decided: Jul 30, 2020 after 190 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: 6 generations back to K910022 (1991). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190620: SpeediCath Flex Coude Pro, Coloplast (2019) Summary page 4.

## Most influential descendants
- K262045: Luja Soft (2026), 0 descendants of its own

## Indications for use
SpeediCath Soft is indicated for use by patients with urine retention and patients with 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 product is for adult male patients only.

Source page: https://510kreport.com/device/K200142
Methodology: https://510kreport.com/methodology