# K222059: SpeediCath Flex Set

- Pathway: 510(k) (Traditional)
- Applicant: Coloplast
- Decided: Sep 21, 2022 after 70 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: 6 generations back to K910022 (1991). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 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.

## Indications for use
SpeediCath Flex Set 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 male patients only.

Source page: https://510kreport.com/device/K222059
Methodology: https://510kreport.com/methodology