Visby Medical, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Visby Medical, Inc.” (first 2021, latest 2026), plus 1 De Novo decision, across 4 product codes in 1 review panel. Median 510(k) review time under this name: 177 days. Since 2017 the median was 177 days, against 177 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2021 | 1 | 521 |
| 2022 | 0 | — |
| 2023 | 1 | 386 |
| 2024 | 0 | — |
| 2025 | 2 | 158 |
| 2026 | 1 | 167 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Visby Medical, Inc. took a median 177 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 177 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QEP | Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections | 3 | 3 |
| QOF | Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents | 1 | 1 |
| SEA | Test For Detection Of Microorganism(S) Causing Sexually Transmitted Infections Performed By Lay Users | 1 | 0 |
| SIA | Over-The-Counter Molecular Multi-Analyte Respiratory Virus Detection Test | 1 | 1 |
Review panels
- Microbiology (6)
Most recent Visby Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253971 | Visby Medical Flu and COVID-19 Test | SIA | 2026-05-27 | 167 |
| K251501 | Visby Medical Men's Sexual Health Test | QEP | 2025-10-01 | 139 |
| K242526 | Visby Medical Respiratory Health Test | QOF | 2025-02-19 | 177 |
| K220407 | Visby Medical Sexual Health Test | QEP | 2023-03-07 | 386 |
| K200748 | Visby Medical Sexual Health | QEP | 2021-08-26 | 521 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN240020 | De Novo | Test For Detection Of Microorganism(S) Causing Sexually Transmitted Infections Performed By Lay Users | 2025-03-28 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2020-12-05.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Visby Medical, Inc. is the lead sponsor of 2 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT04099199: A Healthcare Economic Study of the Click Sexual Health Test (Completed, started 2019-12-03)
- NCT04098900: Clinical Evaluation of the Click Sexual Health Test for the Detection of Neisseria Gonorrhoeae (NG), Trichomonas Vaginalis (TV), and Chlamydia Trachomatis (CT) in Women (Completed, started 2019-09-16)
Frequently asked questions
How many FDA 510(k) clearances are listed under Visby Medical, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Visby Medical, Inc.” (first 2021, latest 2026), plus 1 De Novo decision, across 4 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Visby Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Visby Medical, Inc. is 177 days. Since 2017: 177 days, versus 177 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Visby Medical, Inc.?
The most frequent FDA product codes under this applicant name are QEP (Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections, 3); QOF (Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents, 1); SEA (Test For Detection Of Microorganism(S) Causing Sexually Transmitted Infections Performed By Lay Users, 1).
Next steps
- See all 5 Visby Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code QEP, Visby Medical, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.