Procept Biorobotics: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Procept Biorobotics” (first 2021, latest 2026), plus 1 De Novo decision, across 1 product code in 1 review panel. Median 510(k) review time under this name: 152 days. Since 2017 the median was 152 days, against 152 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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, 510(k)s cleared under the name Procept Biorobotics 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 applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Procept Biorobotics is the 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. An SEC registrant with the same name, matched by name only.
Frequently asked questions
How many FDA 510(k) clearances are listed under Procept Biorobotics?
FDA lists 8 510(k) clearances under the applicant name “Procept Biorobotics” (first 2021, latest 2026), plus 1 De Novo decision, across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Procept Biorobotics?
The median time from FDA receipt to decision across 510(k)s cleared under the name Procept Biorobotics is 152 days. Since 2017: 152 days, versus 152 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Procept Biorobotics?
The most frequent FDA product codes under this applicant name are PZP (Fluid Jet Removal System, 9).
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. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.