# K160942: Sonablate

- Pathway: 510(k) (Traditional)
- Applicant: Sonacare Medical, LLC
- Decided: Dec 21, 2016 after 260 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
No predicates in its family tree.
5 later devices descend from it; 3 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K212150: Exablate Prostate System (2021), 1 descendant of its own
- K172721: Focal One (2018), 1 descendant of its own
- K251910: Focal One® (2025), 0 descendants of its own
- K231378: Exablate Model 2100V1, Exablate Prostate System, Exablate MRgFUS, Exablate 2100V1 Type 3.0 (2023), 0 descendants of its own
- K172285: Ablatherm Fusion (2017), 0 descendants of its own

## Indications for use
The Sonablate® is indicated for transrectal high intensity focused ultrasound (HIFU) ablation of prostatic tissue.

Source page: https://510kreport.com/device/K160942
Methodology: https://510kreport.com/methodology