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 · PZP Fluid Jet Removal System
Cleared on Jun 23, 2026 as substantially equivalent to K241952 (Procept Biorobotics, 2024) after a 267-day review. Its family tree reaches back 5 generations to 2017.
- Decided
- Jun 23, 2026
- Review
- 267 days
- Class
- Class II
- Product code
- PZP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to DEN170024 (2017). No later device cites it as a predicate yet.
- Root · 5 generations backDEN170024 AQUABEAM SystemProcept Biorobotics, Corporation · 2017
- 4 generations backK202961 AquaBeam Robotic SystemProcept Biorobotics, Corporation · 2021 · Recalled
- 3 generations backK212835 AquaBeam Robotic SystemProcept Biorobotics, Corporation · 2021
- 2 generations backK231024 AquaBeam Robotic SystemProcept Biorobotics, Corporation · 2023
- 1 generation backK241952 AQUABEAM Robotic System (AB2000)Procept Biorobotics · 2024
- This deviceK253211 AQUABEAM Robotic SystemProcept Biorobotics · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | DEN170024 | AQUABEAM System | Procept Biorobotics, Corporation | 2017 | — |
| −4 | K202961 | AquaBeam Robotic System | Procept Biorobotics, Corporation | 2021 | 1 |
| −3 | K212835 | AquaBeam Robotic System | Procept Biorobotics, Corporation | 2021 | — |
| −2 | K231024 | AquaBeam Robotic System | Procept Biorobotics, Corporation | 2023 | — |
| −1 | K241952 | AQUABEAM Robotic System (AB2000) | Procept Biorobotics | 2024 | — |
| 0 (this device) | K253211 | AQUABEAM Robotic System | Procept Biorobotics | 2026 | — |
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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K241952 | AQUABEAM Robotic System (AB2000)Summary page 5…dality, to monitor treatment progress. Regulation Number PZP - 21 CFR 876. 4350 Predicate Device Trade Name - AQUABEAM ROBOTIC System 510(k) Number – K241952 cleared on September 30, 2024. Product Code – PZP Regulation Number: 876. 4350 Device Classification - Class II Device Descripti… | 2024 |
What descends from it?
No later submission names this one as a predicate yet.
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 9 years and passes through 2 companies; a new generation was cleared every 1.7 years on median.
- 1 of the 5 ancestors has a recall of any class.
How does its category compare?
All PZP devicesPZP Fluid Jet Removal System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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/K253211 · printed Nov 5, 2026
Cite this page
510(k) Report. “K253211: AQUABEAM Robotic System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K253211
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026