# K142248: Prostiva RF Therapy Generator, Prostiva RF Therapy Hand Piece, Prostiva RF Therapy Return Electrode, Prostiva RF Therapy Tubing System, Prostiva RF Therapy Telescope

- Pathway: 510(k) (Traditional)
- Applicant: Urologix, Inc.
- Decided: Feb 20, 2015 after 190 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K951245 (1995). 10 ancestors in all.
8 later devices descend from it; 1 cites 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.

## Most influential descendants
- K150786: Rezum System (2015), 7 descendants of its own
- 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

## Indications for use
The Prostiva RF Therapy System is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men over the age of 50 with prostate sizes between 20 and 50 cm3.

Source page: https://510kreport.com/device/K142248
Methodology: https://510kreport.com/methodology