# K191505: Rezum System

- Pathway: 510(k) (Special)
- Applicant: Nxthera (A Boston Scientific Company)
- Decided: Aug 2, 2019 after 57 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: 10 generations back to K951245 (1995). 15 ancestors in all.
2 later devices descend 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)
- K190093: Rezum Delivery Device, Rezum Generator, Nxthera (A Boston Scientific Company) (2019) Summary page 4.

## Most influential descendants
- K250584: Rezum System (2025), 1 descendant of its own
- K262460: Rezum System (2026), 0 descendants of its own

## Indications for use
The Rezūm System is intended to relieve symptoms, obstructions, and reduce prostate tissue associated with BPH. It is indicated for men ≥ 50 years of age with a prostate volume ≥ 30cm3 and ≤ 80cm3. 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/K191505
Methodology: https://510kreport.com/methodology