Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Visby Medical, 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) |
|---|---|---|---|---|---|
| K253971 | Visby Medical Flu and COVID-19 Test | Visby Medical, Inc. | 2026-05-27 | 167 | 0 |
| K251501 | Visby Medical Men's Sexual Health Test | Visby Medical, Inc. | 2025-10-01 | 139 | 0 |
| DEN240020 | Visby Medical Women's Sexual Health Test | Visby Medical, Inc. | 2025-03-28 | 319 | 0 |
| K242526 | Visby Medical Respiratory Health Test | Visby Medical, Inc. | 2025-02-19 | 177 | 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