# K251082: HYDROS Robotic System (HY1000); HYDROS Handpiece (HH1000); HYDROS TRUS Probe (HU1000)

- Pathway: 510(k) (Traditional)
- Applicant: Procept Biorobotics
- Decided: Oct 10, 2025 after 184 days
- Product code: PZP (Fluid Jet Removal System)
- Device class: 2
- Regulation: 21 CFR 876.4350
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to DEN170024 (2017). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240200: HYDROS Robotic System; HYDROS TRUS Probe; HYDROS Handpiece, Procept Biorobotics (2024) Summary page 6.

## Indications for use
The HYDROS Robotic System is indicated for the resection and removal of prostate tissue in males suffering from lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia.

Source page: https://510kreport.com/device/K251082
Methodology: https://510kreport.com/methodology