# PZP: Fluid Jet Removal System

- Device class: 2; regulation: 21 CFR 876.4350; FDA's rule: 510(k) required
- FDA decisions: 9
- 510(k) review time 2021–2025: median 152 days (middle half 102–179)
- Recalls: 0 (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)
- 2017: 1
- 2021: 2
- 2023: 1
- 2024: 2
- 2025: 1
- 2026: 2

## Most-cited predicates
- K240200: HYDROS Robotic System; HYDROS TRUS Probe; HYDROS Handpiece (2024), cited by 2
- DEN170024: AQUABEAM System (2017), cited by 2
- K231024: AquaBeam Robotic System (2023), cited by 2
- K212835: AquaBeam Robotic System (2021), cited by 1
- K241952: AQUABEAM Robotic System (AB2000) (2024), cited by 1
- K202961: AquaBeam Robotic System (2021), cited by 1

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