# K203637: SpeediCath Compact (28578, 28580, 28582, 28584), SpeediCath Compact Plus (28810, 28812, 28814)

- Pathway: 510(k) (Traditional)
- Applicant: Coloplast
- Decided: Mar 8, 2022 after 449 days
- Product code: EZD (Catheter, Straight)
- 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: 4 generations back to K910022 (1991). 6 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072808: Speedicath Compact, Coloplast Corp. (2007) 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
- K241028: Luja female (20051); Luja female (20052); Luja female (20054); Luja female (20056) (2024), 0 descendants of its own

## Indications for use
SpeediCath Compact and SpeediCath Compact Plus 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 product is indicated for female patients only (adults and children of and above the age of 2 years). Choice of model and size of the catheter for the individual patient is made upon recommendation by the local health care professional.

Source page: https://510kreport.com/device/K203637
Methodology: https://510kreport.com/methodology