Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Alesi Surgical, Ltd. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
180 daysmedian FDA review time
574 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K231298 | Ultravision2™ System Integrated Monopolar L-Hook (H/S)™ | Alesi Surgical, Ltd. | 2023-10-31 | 180 | 0 |
| K231238 | Ultravision2™ System | Alesi Surgical, Ltd. | 2023-10-31 | 186 | 0 |
| K200035 | Ultravision Visual Field Clearing System | Alesi Surgical, Ltd. | 2020-05-04 | 117 | 0 |
| K182053 | Ultravision™ Visual Field Clearing System | Alesi Surgical, Ltd. | 2018-09-07 | 38 | 0 |
| K170178 | Ultravision Visual Field Clearing System | Alesi Surgical, Ltd. | 2017-05-26 | 127 | 0 |
| DEN150022 | Ultravision Visual Clearing System | Alesi Surgical, Ltd. | 2016-12-20 | 574 | 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