# K240200: HYDROS Robotic System; HYDROS TRUS Probe; HYDROS Handpiece

- Pathway: 510(k) (Traditional)
- Applicant: Procept Biorobotics
- Decided: Aug 20, 2024 after 208 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: 4 generations back to DEN170024 (2017). 4 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231024: AquaBeam Robotic System, Procept Biorobotics, Corporation (2023) Summary page 6.

## Most influential descendants
- K260723: HYDROS Robotic System (HY1000);HYDROS Handpiece (HH1000);HYDROS TRUS Probe (HU1000) (2026), 0 descendants of its own
- K251082: HYDROS Robotic System (HY1000); HYDROS Handpiece (HH1000); HYDROS TRUS Probe (HU1000) (2025), 0 descendants of its own

## Indications for use
The HYDROS™ Robotic System is intended 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/K240200
Methodology: https://510kreport.com/methodology