# P220029: Optilume™ BPH Catheter System

- Pathway: PMA
- Applicant: Urotronic, Inc.
- Decided: Jun 30, 2023 after 200 days
- Product code: QXB (Drug Coated Prostatic Dilation Catheter For Benign Prostatic Hyperplasia)
- Device class: 3
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

Source page: https://510kreport.com/device/P220029
Methodology: https://510kreport.com/methodology