# K180258: SpeediCath Standard

- Pathway: 510(k) (Traditional)
- Applicant: Coloplast
- Decided: Oct 25, 2018 after 268 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.
1 later device descends from it; 1 cites it directly.
0 of 7 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 4.

## Most influential descendants
- K241734: Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter Compact (2025), 0 descendants of its own

## Indications for use
Urinary catheter for intermittent use. The 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 the urine to drain.

Source page: https://510kreport.com/device/K180258
Methodology: https://510kreport.com/methodology