# K211858: TULSA-PRO System

- Pathway: 510(k) (Traditional)
- Applicant: Profound Medical, Inc.
- Decided: Sep 6, 2022 after 447 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: 3 generations back to DEN150011 (2015). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191200: TULSA-PRO System, Profound Medical, Inc. (2019) Summary page 4.

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

Source page: https://510kreport.com/device/K211858
Methodology: https://510kreport.com/methodology