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 Oct 6, 2021 as substantially equivalent to K202961 (Procept Biorobotics, Corporation, 2021) after a 29-day review. Its family tree reaches back 2 generations to 2017. 6 later devices descend from it.
- Decided
- Oct 6, 2021
- Review
- 29 days
- Class
- Class II
- Product code
- PZP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN170024 (2017). 6 later devices descend from it, 1 citing it directly.
- Root · 2 generations backDEN170024 AQUABEAM SystemProcept Biorobotics, Corporation · 2017
- 1 generation backK202961 AquaBeam Robotic SystemProcept Biorobotics, Corporation · 2021 · Recalled
- This deviceK212835 AquaBeam Robotic SystemProcept Biorobotics, Corporation · 2021
- Descendant · cites it directly · 5 of its ownK231024 AquaBeam Robotic SystemProcept Biorobotics, Corporation · 2023
- Descendant · 2 generations on · 2 of its ownK240200 HYDROS Robotic System; HYDROS TRUS Probe; HYDROS HandpieceProcept Biorobotics · 2024
- Descendant · 2 generations on · 1 of its ownK241952 AQUABEAM Robotic System (AB2000)Procept Biorobotics · 2024
- Descendant · 3 generations on · 0 of its ownK260723 HYDROS Robotic System (HY1000);HYDROS Handpiece (HH1000);HYDROS TRUS…Procept Biorobotics · 2026
- Descendant · 3 generations on · 0 of its ownK253211 AQUABEAM Robotic SystemProcept Biorobotics · 2026
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K231024AquaBeam Robotic SystemProcept Biorobotics, Corporation · 2023 · cites it directly5descendants
- K240200HYDROS Robotic System; HYDROS TRUS Probe; HYDROS HandpieceProcept Biorobotics · 2024 · 2 generations on2descendants
- K241952AQUABEAM Robotic System (AB2000)Procept Biorobotics · 2024 · 2 generations on1descendant
- K260723HYDROS Robotic System (HY1000);HYDROS Handpiece (HH1000);HYDROS TRUS Probe (HU1000)Procept Biorobotics · 2026 · 3 generations on0descendants
- K253211AQUABEAM Robotic SystemProcept Biorobotics · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | DEN170024 | AQUABEAM System | Procept Biorobotics, Corporation | 2017 | — |
| −1 | K202961 | AquaBeam Robotic System | Procept Biorobotics, Corporation | 2021 | 1 |
| 0 (this device) | K212835 | AquaBeam Robotic System | Procept Biorobotics, Corporation | 2021 | — |
| +1 | K231024 | AquaBeam Robotic System | Procept Biorobotics, Corporation | 2023 | — |
| +2 | K240200 | HYDROS Robotic System; HYDROS TRUS Probe; HYDROS Handpiece | Procept Biorobotics | 2024 | — |
| +2 | K241952 | AQUABEAM Robotic System (AB2000) | Procept Biorobotics | 2024 | — |
| +3 | K260723 | HYDROS Robotic System (HY1000);HYDROS Handpiece (HH1000);HYDROS TRUS Probe… | Procept Biorobotics | 2026 | — |
| +3 | K253211 | AQUABEAM Robotic System | Procept Biorobotics | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K202961 | AquaBeam Robotic SystemSummary page 4…e device is able to image the treatment area, or pairs with an imaging modality, to monitor treatment progress. Predicate Device AQUABEAM Robotic System 510(k) Number: K202961 on November 04, 2020. Product Code: PZP Regulation Number: 876. 4350 Class II CONFIDENTIAL AQUABEAM Roboti… | 2021 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K231024 | AquaBeam Robotic System | 2023 | 5 |
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 4 years and passes through 1 company; a new generation was cleared every 3.2 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K231024 (Procept Biorobotics, Corporation, 2023) has gone furthest, with 5 descendants of its own.
How does its category compare?
All PZP devicesPZP 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
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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K212835 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212835: 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/K212835
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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