# PLP: High Intensity Ultrasound System For Prostate Tissue Ablation

- Device class: 2; regulation: 21 CFR 876.4340; FDA's rule: 510(k) required
- FDA decisions: 13
- 510(k) review time 2021–2025: median 162 days (middle half 141–186)
- Recalls: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2016: 1
- 2017: 1
- 2018: 1
- 2019: 1
- 2020: 1
- 2021: 1
- 2022: 1
- 2023: 2
- 2024: 1
- 2025: 1

## Most-cited predicates
- K160942: Sonablate (2016), cited by 3
- K153023: Ablatherm Integrated Imaging (2015), cited by 3
- K191200: TULSA-PRO System (2019), cited by 3
- K172721: Focal One (2018), cited by 1
- DEN150011: Sonablate 450 (2015), cited by 1
- K212150: Exablate Prostate System (2021), cited by 1

Source page: https://510kreport.com/product-code/PLP
Data by year (CSV): https://510kreport.com/product-code/PLP.csv