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

K251082

Procept Biorobotics · cleared 2025-10-10 · product code PZP · General and Plastic Surgery

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.6)
“The HYDROS Robotic System, consists of the following nine components: • HYDROS Tower • Touchscreen Interfaces - Monitor that supports the Tower Monitor (Tmon) and Surgeon Monitor (Smon) • HYDROS Software • HYDROS Operating System • Embedded Software • Motorpack • Handpiece Arm • TRUS Probe Arm • Foot Pedal. Optional FirstAssist AI feature available during the PLAN step. FirstAssist AI, Transverse: When the FirstAssist AI toggle button is enabled in the transverse view at the angle and depth step, the software provides the handpiece nozzle position and the prostate capsule boundary.”
AlgorithmFirstAssist AI feature available during the PLAN step. FirstAssist AI, Transverse: When the FirstAssist AI toggle button is enabled in the transverse view at the angle and depth step, the software provides the handpiece nozzle position and the prostate capsule boundary. FirstAssist AI, Sagittal: When the FirstAssist AI toggle button is enabled at the profile landmark step the software will place the 4 landmarks - treatment start (TS), blader neck (BN), mid-prostate (MP) and treatment end (TE). The surgeon has the option to adjust the landmarks as needed. The subject device has an updated AI model for the same functionality of landmark identification.
source quote (p.10)
“Optional FirstAssist AI feature available during the PLAN step. FirstAssist AI, Transverse: When the FirstAssist AI toggle button is enabled in the transverse view at the angle and depth step, the software provides the handpiece nozzle position and the prostate capsule boundary. FirstAssist AI, Sagittal: When the FirstAssist AI toggle button is enabled at the profile landmark step the software will place the 4 landmarks - treatment start (TS), blader neck (BN), mid-prostate (MP) and treatment end (TE). The surgeon has the option to adjust the landmarks as needed. The subject device has an updated AI model for the same functionality of landmark identification.”
Adaptive (vs locked)No
PCCPNo
Cybersecurity addressedYes
source quote (p.26)
“ISO IEC 29147 First edition 2014-02-15 Information technology - Security techniques - Vulnerability disclosure. IEC 80001-1 Edition 1.0 2010-10 Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities. AAMI TIR57:2016 Principles for medical device security - Risk management. ANSI NEMA HN 1-2019 American National Standard Manufacturer Disclosure Statement for Medical Device Security. FDA Guidance Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions. FDA Guidance Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software.”

Validation studies (1)

Bench

sample size not stated

standards: IEC 62366-1:2015/COR1:2016, ANSI/AAMI HE75:2009 (R2018), IEC60601-1-2:2020, IEC TR 60601-4-2, IEC 60601-1:2020, IEC 60601-2-37 Edition 2.1 2015, EC 60601-1-6:2020, IEC 60601-2-18: 2009, IEC 80601-2-77: 2019, AAMI TIR69:2017/(R2020), EN ISO 11135:2014+AMD 1:2019, ISO 10993-7:2008+AMD 1:2019, ISO 11138-1:2017, ISO 11138-2:2017, BS EN 556-1:2001, ISO11737-1:2018+AMD1:2021, ISO 11737-2:2019, ISO 11139:2018, ISO 14937:2009, AAMI TIR 14:2016, AAMI TIR 15:2016, AAMI TIR 16:2017, AAMI TIR 28:2016/(R)2020, ISO 11135 Second edition 2014-07-15, ISO 11737-2 Third edition 2019-12, ISO 10993-1:2018, ISO 10993-4:2017, ISO 10993-5:2009, ISO 10993-9:2019, ISO 10993-10:2021, ISO 10993-11:2017, ISO 10993-12:2021, ISO 10993-13:2010, ISO 10993-14:2001, ISO 10993-15:2019, ISO 10993-18:2020, ISO 10993-23:2021, ISTA 3B:2017, ASTM D4332-22, ASTM D4169-22, ASTM F1886/F1886M-16, ASTM F2096-11 (2019), ISO 11607-1:2019, ISO 11607-2:2019, ASTM F88/F88-2023, ASTM F1980-21, MIL-STD-721C, ISO 15223-1:2021, ISO 20417:2021, ISO 7000:2019, ISO 7010 Third edition 2019-07, ISO 17664-2 First edition 2021-02, IEC/TR 60878 Ed. 4.0 2022-11, ISO 17664-1:2021, ANSI AAMI ST98:2022, AAMI TIR 12:2020, ASTM F3208-20, AAMI TIR 99:2024, ASTM F1089-18, ISO 8600-5:2020, ISO 8600-3:2019, ISO 8600-1:2015, ISO 80369-7:2021, ISO CIE 11664-4, First Edition 2019-06, ISO CIE 11664-6, First Edition 2014-02-01, IEC 61966-2-1:1999-10, IEC 62127-1:2022, IEC 61391-1:2006+AMD1:2017, ISO IEC 29147 First edition 2014-02-15, IEC 80001-1 Edition 1.0 2010-10, AAMI TIR57:2016, ANSI NEMA HN 1-2019

Reported performance (0 observations)

FDA source did not state a quantitative performance metric — non-reporting is itself the signal.

Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.

Predicate network

Postmarket — what happened after clearance

0
recalls in product code, 24mo
217
MAUDE reports in code, 12mo
-23%
vs code's own 3-yr baseline
0
drift signals on this device

Recalls attributed to this device

  • Recalling firm matches this device's applicant (PROCEPT BIOROBOTICS CORPORATION) — same firm and product code, not necessarily this device · initiated 2021-07-09

    Scope tube tip may detach from the telescoping tube, which is attached to a single-use handpiece, a component of an aquablation robotic system. Both tip detachment and entire tip separation form the handpiece may lead to procedural delay for handpiece exchange. Tip detachment can be seen cystoscopically and tip separation from the handpiece may necessitate tip removal from the bladder or prostate.

    recall event 88337 (openFDA)

  • Recalling firm matches this device's applicant (PROCEPT BIOROBOTICS CORPORATION) — same firm and product code, not necessarily this device · initiated 2019-03-06

    Certain lots may develop an internal leak due to a micro-crack in a specific weld joint within the device. When the Robot detects this failure, it immediately renders the device inoperable and notifies the user via an error message, which may cause delay and/or inability to complete the procedure.

    recall event 82462 (openFDA)

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.

Reimbursement — how devices like this got paid

Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the General and Plastic Surgery panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K251082