Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Visioncare Devices, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
108 daysmedian FDA review time
142 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K120170 | PROCARE PLUS VITRECTOMY SYSTEM | Visioncare Devices, Inc. | 2012-05-30 | 132 | 0 |
| K023939 | VELOCITY ADVANTAGE | Visioncare Devices, Inc. | 2003-04-17 | 142 | 0 |
| K971064 | BAYERS BIMANUAL I/A HANDPIECES | Visioncare Devices, Inc. | 1997-06-09 | 77 | 0 |
| K940746 | VIT CUTTER MODEL 94 | Visioncare Devices, Inc. | 1994-06-06 | 108 | 0 |
| K904909 | I/A VITROPHAGE MODEL YPR 2001 | Visioncare Devices, Inc. | 1991-01-28 | 89 | 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