# K250584: Rezum System

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corporation
- Decided: Jun 11, 2025 after 104 days
- Product code: KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories))
- Device class: 2
- Regulation: 21 CFR 876.4300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K951245 (1995). 16 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191505: Rezum System, Nxthera (A Boston Scientific Company) (2019) Summary page 5.

## Most influential descendants
- K262460: Rezum System (2026), 0 descendants of its own

## Indications for use
The Rezam System is intended to relieve symptoms, obstructions, and reduce prostate tissue associated with benign prostatic hyperplasia(BPH). It is indicated for men 2 50 years of age with a prostate volume 30 cm3 150 cm3. The RezOm System is also indicated for treatment of prostate with hyperplasia of the central zone and/or a median lobe.

Source page: https://510kreport.com/device/K250584
Methodology: https://510kreport.com/methodology