Procept Biorobotics: FDA clearances and approvals
Procept Biorobotics has 8 FDA 510(k) clearances (first 2021, latest 2026), plus 1 De Novo decision, across 1 product code in 1 review panel. Median 510(k) review time: 152 days. Since 2017 its median was 152 days, against 152 days for all cleared 510(k)s in the same product codes. openFDA lists 2 product recalls by a recalling firm named Procept Biorobotics. It is the industry lead sponsor of 10 device clinical trials on ClinicalTrials.gov. It files with the SEC as PROCEPT BioRobotics Corp (PRCT).
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2021 | 2 | 96 |
| 2022 | 0 | — |
| 2023 | 1 | 141 |
| 2024 | 2 | 148 |
| 2025 | 1 | 184 |
| 2026 | 2 | 196 |
Review time against the same product codes
Since 2017, Procept Biorobotics's cleared 510(k)s took a median 152 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 152 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| PZP | Fluid Jet Removal System | 9 | 8 |
Review panels
Most recent Procept Biorobotics 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260723 | HYDROS Robotic System (HY1000);HYDROS Handpiece (HH1000);HYDROS TRUS Probe (HU1000) | PZP | 2026-07-09 | 126 |
| K253211 | AQUABEAM Robotic System | PZP | 2026-06-23 | 267 |
| K251082 | HYDROS Robotic System (HY1000); HYDROS Handpiece (HH1000); HYDROS TRUS Probe (HU1000) | PZP | 2025-10-10 | 184 |
| K241952 | AQUABEAM Robotic System (AB2000) | PZP | 2024-09-30 | 89 |
| K240200 | HYDROS Robotic System; HYDROS TRUS Probe; HYDROS Handpiece | PZP | 2024-08-20 | 208 |
| K231024 | AquaBeam Robotic System | PZP | 2023-08-30 | 141 |
| K212835 | AquaBeam Robotic System | PZP | 2021-10-06 | 29 |
| K202961 | AquaBeam Robotic System | PZP | 2021-03-11 | 162 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN170024 | De Novo | Fluid Jet Removal System | 2017-12-21 |
Recalls
2 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2021-07-09.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Device clinical trials
Procept Biorobotics is the industry lead sponsor of 10 device studies on ClinicalTrials.gov (3 active or recruiting). Most recent:
- NCT06651632: WATER IV Prostate Cancer (Active not recruiting, started 2025-02-03)
- NCT06054867: PRCT002 PRostate Cancer Treatment With the AQUABEAM Robotic System (Active not recruiting, started 2024-03-11)
- NCT06051942: PRCT001 Aquablation theraPy Outcomes in pRostate Cancer patienTs (Active not recruiting, started 2022-11-22)
- NCT03191734: French Aquablation Clinical Investigation Using Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue (Completed, started 2017-09-19)
- NCT03123250: Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue II (Completed, started 2017-08-14)
SEC filings
PROCEPT BioRobotics Corp (PRCT): EDGAR filings, CIK 1588978. Matched by exact company name.
Frequently asked questions
How many FDA 510(k) clearances does Procept Biorobotics have?
Procept Biorobotics has 8 FDA 510(k) clearances (first 2021, latest 2026), plus 1 De Novo decision, across 1 product code in 1 review panel.
How long does FDA take to clear Procept Biorobotics's 510(k)s?
The median time from FDA receipt to decision across Procept Biorobotics's cleared 510(k)s is 152 days. Since 2017: 152 days, versus 152 days for all cleared 510(k)s in the same product codes.
What devices does Procept Biorobotics make?
Its most frequent FDA product codes are PZP (Fluid Jet Removal System, 9).
Has Procept Biorobotics had device recalls?
openFDA lists 2 product recalls in 2 recall events by a recalling firm whose name matches Procept Biorobotics; the most recent began 2021-07-09. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 8 Procept Biorobotics clearances with predicates and recalls
- Run predicate analysis for product code PZP, Procept Biorobotics's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.