# K192904: SpeediCath Compact Set

- Pathway: 510(k) (Traditional)
- Applicant: Coloplast
- Decided: Nov 2, 2020 after 384 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: 5 generations back to K910022 (1991). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121457: Speedicath Compact Set (12 FR), Coloplast Corp. (2012) Summary page 4.

## Indications for use
SpeediCath 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. This device is intended for females only.

Source page: https://510kreport.com/device/K192904
Methodology: https://510kreport.com/methodology