# K212150: Exablate Prostate System

- Pathway: 510(k) (Traditional)
- Applicant: Insightec, Inc.
- Decided: Nov 23, 2021 after 137 days
- Product code: PLP (High Intensity Ultrasound System For Prostate Tissue Ablation)
- Device class: 2
- Regulation: 21 CFR 876.4340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K160942 (2016). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160942: Sonablate, Sonacare Medical, LLC (2016) Summary page 4.

## Most influential descendants
- K231378: Exablate Model 2100V1, Exablate Prostate System, Exablate MRgFUS, Exablate 2100V1 Type 3.0 (2023), 0 descendants of its own

## Indications for use
The Exablate Prostate System is indicated for endorectal MR-Guided Focused Ultrasound (MRgFUS) ablation of Prostatic Tissue

Source page: https://510kreport.com/device/K212150
Methodology: https://510kreport.com/methodology