Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Vitromed GmbH — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
247 daysmedian FDA review time
359 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K241833 | V-GRAD | Vitromed GmbH | 2025-03-21 | 269 | 0 |
| K240176 | V-VITFREEZE and V-VITWARM | Vitromed GmbH | 2024-09-13 | 234 | 0 |
| K232125 | V-PVP | Vitromed GmbH | 2024-03-20 | 247 | 0 |
| K222606 | V-HYADASE | Vitromed GmbH | 2023-05-26 | 270 | 0 |
| K223117 | V-SPERM WASH | Vitromed GmbH | 2023-01-31 | 120 | 0 |
| K193285 | V-ONESTEP | Vitromed GmbH | 2020-11-20 | 359 | 0 |
| K192146 | V-DENUPET | Vitromed GmbH | 2020-01-28 | 173 | 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