510(k) Report

510(k) · Cleared

Recalled · Class II · 2021

AquaBeam Robotic System

K202961510(k) TraditionalCleared Mar 11, 2021162-day reviewClass II21 CFR 876.4350Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Procept Biorobotics, Corporation · PZP Fluid Jet Removal System

Cleared on Mar 11, 2021 as substantially equivalent to DEN170024 (Procept Biorobotics, Corporation, 2017) after a 162-day review. Its family tree reaches back 1 generation to 2017. 7 later devices descend from it. It has been recalled once.

Decided
Mar 11, 2021
Review
162 days
Class
Class II
Product code
PZP
Recalls
1
Predicates
1

Its longest line of descent runs back 1 generation to DEN170024 (2017). 7 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2021: 1 descendant cleared2023: 1 descendant cleared2024: 2 descendants cleared2025: 1 descendant cleared2026: 2 descendants clearedDEN170024 · AQUABEAM System · Procept Biorobotics, Corporation · 2017201620182020202220242026
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 1 descendant3 generations forward: 2 descendants4 generations forward: 3 descendants DEN170024 · AQUABEAM System · Procept Biorobotics, Corporation · 20170
  1. Root · 1 generation backDEN170024 AQUABEAM SystemProcept Biorobotics, Corporation · 2017
  2. This deviceK202961 AquaBeam Robotic SystemProcept Biorobotics, Corporation · 2021
  3. Descendant · cites it directly · 6 of its ownK212835 AquaBeam Robotic SystemProcept Biorobotics, Corporation · 2021
  4. Descendant · 2 generations on · 5 of its ownK231024 AquaBeam Robotic SystemProcept Biorobotics, Corporation · 2023
  5. Descendant · 3 generations on · 2 of its ownK240200 HYDROS Robotic System; HYDROS TRUS Probe; HYDROS HandpieceProcept Biorobotics · 2024
  6. Descendant · 3 generations on · 1 of its ownK241952 AQUABEAM Robotic System (AB2000)Procept Biorobotics · 2024
  7. Descendant · 4 generations on · 0 of its ownK260723 HYDROS Robotic System (HY1000);HYDROS Handpiece (HH1000);HYDROS TRUS…Procept Biorobotics · 2026

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2021: 12023: 12024: 22025: 12026: 2
2021high 2 (2024) · low 0 (2022)2026

Most influential descendants

Showing 5 of 7 · See all
  • K212835AquaBeam Robotic SystemProcept Biorobotics, Corporation · 2021 · cites it directly6descendants
  • K231024AquaBeam Robotic SystemProcept Biorobotics, Corporation · 2023 · 2 generations on5descendants
  • K240200HYDROS Robotic System; HYDROS TRUS Probe; HYDROS HandpieceProcept Biorobotics · 2024 · 3 generations on2descendants
  • K241952AQUABEAM Robotic System (AB2000)Procept Biorobotics · 2024 · 3 generations on1descendant
  • K260723HYDROS Robotic System (HY1000);HYDROS Handpiece (HH1000);HYDROS TRUS Probe (HU1000)Procept Biorobotics · 2026 · 4 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1DEN170024AQUABEAM SystemProcept Biorobotics, Corporation2017—
0 (this device)K202961AquaBeam Robotic SystemProcept Biorobotics, Corporation2021—
+1K212835AquaBeam Robotic SystemProcept Biorobotics, Corporation2021—
+2K231024AquaBeam Robotic SystemProcept Biorobotics, Corporation2023—
+3K240200HYDROS Robotic System; HYDROS TRUS Probe; HYDROS HandpieceProcept Biorobotics2024—
+3K241952AQUABEAM Robotic System (AB2000)Procept Biorobotics2024—
+4K260723HYDROS Robotic System (HY1000);HYDROS Handpiece (HH1000);HYDROS TRUS Probe…Procept Biorobotics2026—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202110
202310
202420
202510
202620
FIG. 1 — Lineage of K202961, 2017–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in PZP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new PZP device

  1. #1 K240200 HYDROS Robotic System; HYDROS TRUS Probe…score 14.8 · 4 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*DEN170024AQUABEAM System
Summary page 4
…vice is able to image the treatment area, or pairs with an imaging modality, to monitor treatment progress. Predicate Device Trade Name: AQUABEAM System 510(k) Number: DEN170024 on 21 December 2017. Product Code: PZP Regulation Number: 876. 4350 Class II PROCEPT BioRobotics Corporation · 90…
Procept Biorobotics, Corporation2017—

Also cleared against DEN170024: 1 other device →

What descends from it? (7)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K212835AquaBeam Robotic SystemProcept Biorobotics, Corporation20216

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jul 9, 2021Class IIZ-2330-2021Component change controlScope 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…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has no recall.
  • Of its descendants, K212835 (Procept Biorobotics, Corporation, 2021) has gone furthest, with 6 descendants of its own.
  • 1 other device also cites its predicate DEN170024.

How does its category compare?

All PZP devices

PZP Fluid Jet Removal System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.

FDA decisions per year · PZP

1in 2025

2017: 12021: 22023: 12024: 22025: 12026 (partial year): 2
2007high 2 (2021) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · PZP

Too few PZP 510(k)s in any year since 2007 to give a median.

Recalls per year · PZP

No recall names PZP since 2007.

Adverse event reports per year · PZP

290in 2025

2018: 142019: 702020: 852021: 992022: 1742023: 2542024: 3092025: 290
2007high 309 (2024) · low 0 (2007)2025

MAUDE reports naming product code PZP, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20171—00
20180—014
20190—070
20200—085
20212—099
20220—0174
20231—0254
20242—0309
20251—0290
20262—0—

What is it indicated for?

The AQUABEAM 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.

Indications for use as stated in the FDA summary.

Also cleared against DEN170024

1 other device cites the same predicate.

  • K231024AquaBeam Robotic SystemProcept Biorobotics, Corporation · 2023

More from Procept Biorobotics, Corporation

4 FDA decisions under this applicant name. See the company

  • K231024AquaBeam Robotic SystemProcept Biorobotics, Corporation · 2023
  • K212835AquaBeam Robotic SystemProcept Biorobotics, Corporation · 2021
  • DEN170024AQUABEAM SystemProcept Biorobotics, Corporation · 2017

Recent decisions in PZP

The PZP category page

  • K260723HYDROS Robotic System (HY1000);HYDROS Handpiece (HH1000);HYDROS TRUS Probe (HU1000)Procept Biorobotics · 2026
  • K253211AQUABEAM Robotic SystemProcept Biorobotics · 2026
  • K251082HYDROS Robotic System (HY1000); HYDROS Handpiece (HH1000); HYDROS TRUS Probe (HU1000)Procept Biorobotics · 2025
  • K241952AQUABEAM Robotic System (AB2000)Procept Biorobotics · 2024
  • K240200HYDROS Robotic System; HYDROS TRUS Probe; HYDROS HandpieceProcept Biorobotics · 2024

https://510kreport.com/device/K202961 · printed Nov 6, 2026

Cite this page

510(k) Report. “K202961: AquaBeam Robotic System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202961

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026