Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Procept Biorobotics — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
184 daysmedian FDA review time
267 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260723 | HYDROS Robotic System (HY1000);HYDROS Handpiece (HH1000);HYD | Procept Biorobotics | 2026-07-09 | 126 | 0 |
| K253211 | AQUABEAM Robotic System | Procept Biorobotics | 2026-06-23 | 267 | 0 |
| K251082 | HYDROS Robotic System (HY1000); HYDROS Handpiece (HH1000); H | Procept Biorobotics | 2025-10-10 | 184 | 0 |
| K241952 | AQUABEAM Robotic System (AB2000) | Procept Biorobotics | 2024-09-30 | 89 | 0 |
| K240200 | HYDROS Robotic System; HYDROS TRUS Probe; HYDROS Handpiece | Procept Biorobotics | 2024-08-20 | 208 | 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