510(k) · Cleared
ClearedAquaBeam Robotic System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Procept Biorobotics, Corporation · PZP Fluid Jet Removal System
Cleared on Aug 30, 2023 as substantially equivalent to DEN170024 (Procept Biorobotics, Corporation, 2017) and 1 other predicate after a 141-day review. Its family tree reaches back 3 generations to 2017. 5 later devices descend from it.
- Decided
- Aug 30, 2023
- Review
- 141 days
- Class
- Class II
- Product code
- PZP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to DEN170024 (2017). 5 later devices descend from it, 2 citing it directly.
- Root · 3 generations backDEN170024 AQUABEAM SystemProcept Biorobotics, Corporation · 2017
- 2 generations backK202961 AquaBeam Robotic SystemProcept Biorobotics, Corporation · 2021 · Recalled
- 1 generation backK212835 AquaBeam Robotic SystemProcept Biorobotics, Corporation · 2021
- This deviceK231024 AquaBeam Robotic SystemProcept Biorobotics, Corporation · 2023
- Descendant · cites it directly · 2 of its ownK240200 HYDROS Robotic System; HYDROS TRUS Probe; HYDROS HandpieceProcept Biorobotics · 2024
- Descendant · cites it directly · 1 of its ownK241952 AQUABEAM Robotic System (AB2000)Procept Biorobotics · 2024
- Descendant · 2 generations on · 0 of its ownK260723 HYDROS Robotic System (HY1000);HYDROS Handpiece (HH1000);HYDROS TRUS…Procept Biorobotics · 2026
- Descendant · 2 generations on · 0 of its ownK253211 AQUABEAM Robotic SystemProcept Biorobotics · 2026
- Descendant · 2 generations on · 0 of its ownK251082 HYDROS Robotic System (HY1000); HYDROS Handpiece (HH1000); HYDROS…Procept Biorobotics · 2025
Most influential descendants
Showing 5 of 5 · See all- K240200HYDROS Robotic System; HYDROS TRUS Probe; HYDROS HandpieceProcept Biorobotics · 2024 · cites it directly2descendants
- K241952AQUABEAM Robotic System (AB2000)Procept Biorobotics · 2024 · cites it directly1descendant
- K260723HYDROS Robotic System (HY1000);HYDROS Handpiece (HH1000);HYDROS TRUS Probe (HU1000)Procept Biorobotics · 2026 · 2 generations on0descendants
- K253211AQUABEAM Robotic SystemProcept Biorobotics · 2026 · 2 generations on0descendants
- K251082HYDROS Robotic System (HY1000); HYDROS Handpiece (HH1000); HYDROS TRUS Probe (HU1000)Procept Biorobotics · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | DEN170024 | AQUABEAM System | Procept Biorobotics, Corporation | 2017 | — |
| −2 | K202961 | AquaBeam Robotic System | Procept Biorobotics, Corporation | 2021 | 1 |
| −1 | K212835 | AquaBeam Robotic System | Procept Biorobotics, Corporation | 2021 | — |
| 0 (this device) | K231024 | AquaBeam Robotic System | Procept Biorobotics, Corporation | 2023 | — |
| +1 | K240200 | HYDROS Robotic System; HYDROS TRUS Probe; HYDROS Handpiece | Procept Biorobotics | 2024 | — |
| +1 | K241952 | AQUABEAM Robotic System (AB2000) | Procept Biorobotics | 2024 | — |
| +2 | K260723 | HYDROS Robotic System (HY1000);HYDROS Handpiece (HH1000);HYDROS TRUS Probe… | Procept Biorobotics | 2026 | — |
| +2 | K253211 | AQUABEAM Robotic System | Procept Biorobotics | 2026 | — |
| +2 | K251082 | HYDROS Robotic System (HY1000); HYDROS Handpiece (HH1000); HYDROS TRUS Probe… | Procept Biorobotics | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 0 |
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 K240200 HYDROS Robotic System; HYDROS TRUS Probe…score 14.8 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | DEN170024 | AQUABEAM SystemSummary page 4…System AQUABEAM® Robotic System Clearance Number DEN170024 K212835 Product Code PZP PZP 4. Device Des… | 2017 |
| * | K212835 | AquaBeam Robotic SystemSummary page 4…Robotic System Clearance Number DEN170024 K212835 Product Code PZP PZP 4. Device Description The AQUABEAM® Robotic… | 2021 |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 6 years and passes through 1 company; a new generation was cleared every 1.9 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K240200 (Procept Biorobotics, 2024) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate DEN170024.
How does its category compare?
All PZP devicesPZP Fluid Jet Removal System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · PZP
1in 2025
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
MAUDE reports naming product code PZP, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 14 |
| 2019 | 0 | — | 0 | 70 |
| 2020 | 0 | — | 0 | 85 |
| 2021 | 2 | — | 0 | 99 |
| 2022 | 0 | — | 0 | 174 |
| 2023 | 1 | — | 0 | 254 |
| 2024 | 2 | — | 0 | 309 |
| 2025 | 1 | — | 0 | 290 |
| 2026 | 2 | — | 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.
https://510kreport.com/device/K231024 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231024: 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/K231024
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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