Total clearances
6
2021-08-26 → 2026-05-27
Name variants in FDA filings: Visby Medical, Inc. / Visby Medical
Trend
Clearance cadence by quarter
Portfolio
Product codes worked
| Code |
Device name |
Class |
Specialty |
Clearances |
Most recent |
| QEP |
Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections |
Class II |
Microbiology |
3 |
2025-10-01 |
| SIA |
Over-The-Counter Molecular Multi-Analyte Respiratory Virus Detection Test |
Class II |
Microbiology |
1 |
2026-05-27 |
| SEA |
Test For Detection Of Microorganism(S) Causing Sexually Transmitted Infections Performed By Lay Users |
Class II |
Microbiology |
1 |
2025-03-28 |
| QOF |
Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents |
Class II |
Microbiology |
1 |
2025-02-19 |
Safety
Recalls (1)
Class I (serious)
0
Risk of injury / death
| Date | Severity | Status | Recall # |
Product | Code | Reason |
| 2020-12-05 |
Class II
|
Terminated |
Z-0847-2021 |
visby medical COVID-19 Test kit *** An in vitro diagnostic for the qualitative detection of SARS-CoV-2 - Product Usage: … |
— |
Two issues: 1) 5 Lots were found to have incorrect labeling on the outer box stating that the product is CLIA Waived. 2) 3 Lots contain a kit component that e… |
Filings
All 510(k) clearances (6)
| Date |
K-number |
Device |
Code |
Class |
Specialty |
| 2026-05-27 |
K253971 |
Visby Medical Flu and COVID-19 Test |
SIA |
Class II |
Microbiology |
| 2025-10-01 |
K251501 |
Visby Medical Men's Sexual Health Test |
QEP |
Class II |
Microbiology |
| 2025-03-28 |
DEN240020 |
Visby Medical Women's Sexual Health Test |
SEA |
Class II |
Microbiology |
| 2025-02-19 |
K242526 |
Visby Medical Respiratory Health Test |
QOF |
Class II |
Microbiology |
| 2023-03-07 |
K220407 |
Visby Medical Sexual Health Test |
QEP |
Class II |
Microbiology |
| 2021-08-26 |
K200748 |
Visby Medical Sexual Health |
QEP |
Class II |
Microbiology |