# K191200: TULSA-PRO System

- Pathway: 510(k) (Traditional)
- Applicant: Profound Medical, Inc.
- Decided: Aug 15, 2019 after 101 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: 2 generations back to DEN150011 (2015). 2 ancestors in all.
3 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)
- K153023: Ablatherm Integrated Imaging, Edap Technomed, Inc. (2015) Summary page 5.

## Most influential descendants
- K230692: TULSA-PRO System (2023), 0 descendants of its own
- K211858: TULSA-PRO System (2022), 0 descendants of its own
- K202286: Tulsa-Pro System (2020), 0 descendants of its own

## Indications for use
The TULSA-PRO System is indicated for transurethral ultrasound ablation (TULSA) of prostate tissue.

Source page: https://510kreport.com/device/K191200
Methodology: https://510kreport.com/methodology