# K253525: Urocross Expander System (Model Numbers ES2018 and ES3025)

- Pathway: 510(k) (Traditional)
- Applicant: Prodeon Medical, Inc.
- Decided: Mar 12, 2026 after 119 days
- Product code: QKA (Temporarily-Placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia)
- Device class: 2
- Regulation: 21 CFR 876.5510
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN190020 (2020). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN190020: iTind System, Medi-Tate, Ltd. (2020) Summary page 5.

## Most influential descendants
- K261342: Urocross Expander System (UES-2018-C1) (2026), 0 descendants of its own

## Indications for use
The Urocross Expander System is intended to relieve urinary outflow obstruction. The Urocross Expander System is indicated for the treatment of lower urinary tract symptoms (LUTS) attributed to benign prostatic hyperplasia (BPH) in men ≥ 45 years old. The Urocross Expander Implant is indicated for an indwell duration of up to 6 months.

Source page: https://510kreport.com/device/K253525
Methodology: https://510kreport.com/methodology