# K262045: Luja Soft

- Pathway: 510(k) (Special)
- Applicant: Coloplast A.S.
- Decided: Jul 7, 2026 after 20 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: 7 generations back to K910022 (1991). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200142: SpeediCath Soft, Coloplast (2020) Summary page 6.

## Indications for use
Luja Soft 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 adult male patients only.

Source page: https://510kreport.com/device/K262045
Methodology: https://510kreport.com/methodology