# DEN150011: Sonablate 450

- Pathway: De Novo (Direct)
- Applicant: Sonacare Medical, LLC
- Decided: Oct 9, 2015 after 200 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.
8 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K153023: Ablatherm Integrated Imaging (2015), 7 descendants of its own
- K191200: TULSA-PRO System (2019), 3 descendants of its own
- K172721: Focal One (2018), 1 descendant of its own
- K251910: Focal One® (2025), 0 descendants of its own
- K230692: TULSA-PRO System (2023), 0 descendants of its own

## Indications for use
transrectal high intensity focused ultrasound (HIFU) ablation of prostatic tissue.

Source page: https://510kreport.com/device/DEN150011
Methodology: https://510kreport.com/methodology