De Novo · Granted
GrantedAQUABEAM 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
Granted on Dec 21, 2017 as a new device type through De Novo after a 248-day review. 8 later devices descend from it.
- Decided
- Dec 21, 2017
- Review
- 248 days
- Class
- Class II
- Product code
- PZP
- Recalls
- None
8 later devices descend from it, 2 citing it directly.
- This deviceDEN170024 AQUABEAM SystemProcept Biorobotics, Corporation · 2017
- Descendant · cites it directly · 7 of its ownK202961 AquaBeam Robotic SystemProcept Biorobotics, Corporation · 2021 · Recalled
- Descendant · 2 generations on · 6 of its ownK212835 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
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K202961AquaBeam Robotic SystemProcept Biorobotics, Corporation · 2021 · cites it directly7descendants
- K212835AquaBeam Robotic SystemProcept Biorobotics, Corporation · 2021 · 2 generations on6descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN170024 | AQUABEAM System | Procept Biorobotics, Corporation | 2017 | — |
| +1 | K202961 | AquaBeam Robotic System | Procept Biorobotics, Corporation | 2021 | 1 |
| +2 | 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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 0 |
Sources: FDA De Novo 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
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (8)
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?
- Of its descendants, K202961 (Procept Biorobotics, Corporation, 2021) has gone furthest, with 7 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. 2017, 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 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/DEN170024 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN170024: AQUABEAM System.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN170024
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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