De Novo · Granted
GrantedVisby Medical Women's Sexual Health Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Visby Medical, Inc. · SEA Test For Detection Of Microorganism (S) Causing Sexually Transmitted Infections Performed By Lay Users
Granted on Mar 28, 2025 as a new device type through De Novo after a 319-day review.
- Decided
- Mar 28, 2025
- Review
- 319 days
- Class
- Class II
- Product code
- SEA
- Recalls
- None
De Novo grants create a new device type without a predicate, so this family tree starts here.
Sources: FDA De Novo database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in SEA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All SEA devicesSEA Test For Detection Of Microorganism (S) Causing Sexually Transmitted Infections Performed By Lay Users: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · SEA
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · SEA
Too few SEA 510(k)s in any year since 2007 to give a median.
Recalls per year · SEA
No recall names SEA since 2007.
Adverse event reports per year · SEA
No MAUDE report names SEA since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Visby Medical Women's Sexual Health Test is a single use (disposable), automated PCR (Polymerase Chain Reaction) in vitro diagnostic self-test for the rapid detection and differentiation of DNA from Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis in self-collected vaginal swab specimens. This test is intended to be sold over-the-counter (OTC) for use by females suspected of sexually transmitted infection with Chlamydia…
Read the full statement (101 words)
The Visby Medical Women's Sexual Health Test is a single use (disposable), automated PCR (Polymerase Chain Reaction) in vitro diagnostic self-test for the rapid detection and differentiation of DNA from Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis in self-collected vaginal swab specimens. This test is intended to be sold over-the-counter (OTC) for use by females suspected of sexually transmitted infection with Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis. This test is not a substitute for visits to a healthcare provider. The information provided by this product should not be used to start, stop or change any treatments without a healthcare provider.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN240020 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN240020: Visby Medical Women's Sexual Health Test.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN240020
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026