# K150786: Rezum System

- Pathway: 510(k) (Traditional)
- Applicant: Nxthera, Inc.
- Decided: Aug 27, 2015 after 155 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: 6 generations back to K951245 (1995). 11 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113380: Prostiva RF Therapy Hand Piece Prostiva RF Therapy RF Generator, Medtronic, Inc. (2012) Summary page 4.
- K142248: Prostiva RF Therapy Generator, Prostiva RF Therapy Hand Piece, Prostiva RF Therapy Return Electrode, Prostiva RF Therapy Tubing System, Prostiva RF Therapy Telescope, Urologix, Inc. (2015) Summary page 4.

## Most influential descendants
- K160417: Rezum System (2016), 5 descendants of its own
- K180237: Rezum System (2018), 4 descendants of its own
- K190093: Rezum Delivery Device, Rezum Generator (2019), 3 descendants of its own
- K191505: Rezum System (2019), 2 descendants of its own
- K250584: Rezum System (2025), 1 descendant of its own

## Indications for use
The Reziim 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 > 30cm® and < 80cm?. The Reziim 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/K150786
Methodology: https://510kreport.com/methodology