Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Procept Biorobotics, Corporation · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K231024 | AquaBeam Robotic System | Procept Biorobotics, Corporation | 2023-08-30 | 141 | 0 |
| K212835 | AquaBeam Robotic System | Procept Biorobotics, Corporation | 2021-10-06 | 29 | 0 |
| K202961 | AquaBeam Robotic System | Procept Biorobotics, Corporation | 2021-03-11 | 162 | 0 |
| DEN170024 | AQUABEAM System | Procept Biorobotics, Corporation | 2017-12-21 | 248 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda