# K250910: Optilume® High Pressure Urological Balloon Dilation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Urotronic, Inc.
- Decided: May 22, 2025 after 57 days
- Product code: EZN (Dilator, Catheter, Ureteral)
- Device class: 2
- Regulation: 21 CFR 876.5470
- 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 K952968 (1995). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130804: Uromax Ultra Balloon Dilatation Catheter, Boston Scientific Corporation (2013) Summary page 5.

## Indications for use
The Optilume® High Pressure Urological Balloon Dilation Catheter is indicated for dilation of the urinary tract.

Source page: https://510kreport.com/device/K250910
Methodology: https://510kreport.com/methodology