# K160417: Rezum System

- Pathway: 510(k) (Special)
- Applicant: Nxthera, Inc.
- Decided: Mar 17, 2016 after 30 days
- Product code: KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories))
- Device class: 2
- Regulation: 21 CFR 876.4300
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K951245 (1995). 12 ancestors in all.
5 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)
- K150786: Rezum System, Nxthera, Inc. (2015) Summary page 4.

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

## Recalls of this device
- Jul 28, 2017 · Class II · Z-0262-2018: Needle Bond may not be able to withstand the tension force applied when the shaped needle is deployed into and retracted from prostate tissue to deliver treatments.

## 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/K160417
Methodology: https://510kreport.com/methodology