# K161672: SpeediCath Flex Coude

- Pathway: 510(k) (Traditional)
- Applicant: Coloplast Corp.
- Decided: Sep 29, 2016 after 112 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.
10 later devices descend from it; 1 cites it directly.
0 of 16 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
- K180070: SpeediCath Flex Coude Pro (2018), 9 descendants of its own
- K190620: SpeediCath Flex Coude Pro (2019), 8 descendants of its own
- K230165: Luja Coudé (20118 Male CH8 - small packaging (Pocket size)), Luja Coudé (20111 Male CH10 - small packaging (Pocket size)), Luja Coudé (20112 Male CH12 - small packaging (Pocket size)), Luja Coudé (20114 Male CH14 - small packaging (Pocket size)), Luja Coudé  (20101 Male CH10 - large packaging), Luja Coudé  (20102 Male CH12 - large packaging), Luja Coudé  (20104 Male CH14 - large packaging), Luja Coudé  (20106 Male CH16 - large packaging) (2023), 4 descendants of its own
- K241210: Luja Coude (2024), 2 descendants of its own
- K200142: SpeediCath Soft (2020), 1 descendant of its own

## Indications for use
The catheter is indicated for use by patients with 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 for male patients only.

Source page: https://510kreport.com/device/K161672
Methodology: https://510kreport.com/methodology