# K250270: Luja Set

- Pathway: 510(k) (Special)
- Applicant: Coloplast Corp.
- Decided: Apr 17, 2025 after 77 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: 8 generations back to K910022 (1991). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K241210: Luja Coude, Coloplast Corp. (2024) Summary page 6.

## Indications for use
Luja 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 indicated for male patients only (adults and pediatric above the age of 1 years).

Source page: https://510kreport.com/device/K250270
Methodology: https://510kreport.com/methodology