Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Restoration Robotics, Inc. · 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) |
|---|---|---|---|---|---|
| K173358 | ARTAS System | Restoration Robotics, Inc. | 2018-03-16 | 142 | 0 |
| K123548 | THE ARTAS SYSTEM | Restoration Robotics, Inc. | 2013-02-25 | 98 | 4 |
| K123154 | ARTAS SYSTEM FROM RESTORATION ROBOTICS | Restoration Robotics, Inc. | 2013-02-19 | 133 | 0 |
| K103428 | THE ARTAS SYSTEM FROM RESTORATION ROBOTICS | Restoration Robotics, Inc. | 2011-04-04 | 133 | 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