510(k) · Cleared
ClearedVisby Medical Men's Sexual Health Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Visby Medical, Inc. · QEP Nucleic Acid Detection System For Non-Viral Microorganism (S) Causing Sexually Transmitted Infections
Cleared on Oct 1, 2025 as substantially equivalent to K220407 (Visby Medical, 2023) after a 139-day review. Its family tree reaches back 6 generations to 1996.
- Decided
- Oct 1, 2025
- Review
- 139 days
- Class
- Class II
- Product code
- QEP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to P950039 (1996). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backP950039 Thinprep (R) Processor, Model TP 2000Hologic, Inc. · 1996
- 5 generations backK043224 Gen-Probe Aptima Combo 2 AssayGen-Probe, Inc. · 2005
- 4 generations backK121710 Xpert CT/NGCepheid · 2012 · Recalled
- 3 generations backK151565 Xpert® TV Assay on the Cepheid GeneXpert Instrument Systems…Cepheid · 2015
- 2 generations backK200748 Visby Medical Sexual HealthVisby Medical · 2021
- 1 generation backK220407 Visby Medical Sexual Health TestVisby Medical · 2023
- This deviceK251501 Visby Medical Men's Sexual Health TestVisby Medical, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | P950039 | Thinprep (R) Processor, Model TP 2000 | Hologic, Inc. | 1996 | — |
| −5 | K043224 | Gen-Probe Aptima Combo 2 Assay | Gen-Probe, Inc. | 2005 | — |
| −4 | K121710 | Xpert CT/NG | Cepheid | 2012 | 3 |
| −3 | K151565 | Xpert® TV Assay on the Cepheid GeneXpert Instrument Systems (GeneXpert Dx… | Cepheid | 2015 | — |
| −2 | K200748 | Visby Medical Sexual Health | Visby Medical | 2021 | — |
| −1 | K220407 | Visby Medical Sexual Health Test | Visby Medical | 2023 | — |
| 0 (this device) | K251501 | Visby Medical Men's Sexual Health Test | Visby Medical, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 2 | 0 |
| 2005 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
Sources: FDA 510(k) 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 QEP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QEP device
- #1 K260917 cobas CT/NG for use on the cobas…score 13.7 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K220407 | Visby Medical Sexual Health TestSummary page 5…ation: Class II Regulation: 21 CFR 866.3393 Primary Product Code: QEP C. Predicate Device Visby Medical Sexual Health Test (K220407) D. Device Description The Visby Medical Men’s Sexual Health Test is a single-use (disposable), fully automate… | 2023 |
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.
What does this lineage say?
- The line of descent spans 29 years and passes through 5 companies; a new generation was cleared every 5.9 years on median.
- 2 of the 11 ancestors have a recall of any class.
How does its category compare?
All QEP devicesQEP Nucleic Acid Detection System For Non-Viral Microorganism (S) Causing Sexually Transmitted Infections: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · QEP
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QEP
268in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QEP
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QEP
9in 2025
MAUDE reports naming product code QEP, not matched to any one device; reports are not rates.
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 | 5 | 85 | 0 | 0 |
| 2020 | 3 | 46 | 0 | 0 |
| 2021 | 3 | 521 | 0 | 1 |
| 2022 | 3 | 438 | 0 | 1 |
| 2023 | 3 | 325 | 0 | 8 |
| 2024 | 0 | — | 3 | 8 |
| 2025 | 4 | 268 | 0 | 9 |
| 2026 | 3 | 171 | 0 | — |
What is it indicated for?
The Visby Medical Men’s Sexual Health Test is a single-use (disposable), fully integrated, automated Polymerase Chain Reaction (PCR) in vitro diagnostic test for the rapid detection and differentiation of DNA from Chlamydia trachomatis and Neisseria gonorrhoeae in male urine specimens. The test results are to aid in the diagnosis of symptomatic or asymptomatic infections with Chlamydia trachomatis and Neisseria gonorrhoeae in males.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251501 · printed Nov 5, 2026
Cite this page
510(k) Report. “K251501: Visby Medical Men's Sexual Health Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K251501
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026