# K262460: Rezum System

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific
- Decided: Sep 3, 2026 after 48 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: 12 generations back to K951245 (1995). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K250584: Rezum System, Boston Scientific Corporation (2025) Summary page 5.

## Indications for use
The Rezūm System is intended to relieve symptoms, obstructions, and reduce prostate tissue associated with benign prostatic hyperplasia (BPH). It is indicated for men ≥ 50 years of age with a prostate volume 30 cm3 ≤ 150 cm3. The Rezūm 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/K262460
Methodology: https://510kreport.com/methodology