510(k) · Cleared
ClearedVisby Medical Flu and COVID-19 Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Visby Medical, Inc. · SIA Over-The-Counter Molecular Multi-Analyte Respiratory Virus Detection Test
Cleared on May 27, 2026 as substantially equivalent to DEN220028 (Cue Health, Inc., 2023) after a 167-day review. Its family tree reaches back 1 generation to 2023.
- Decided
- May 27, 2026
- Review
- 167 days
- Class
- Class II
- Product code
- SIA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN220028 (2023). No later device cites it as a predicate yet.
- Root · 1 generation backDEN220028 Cue COVID-19 Molecular TestCue Health, Inc. · 2023
- This deviceK253971 Visby Medical Flu and COVID-19 TestVisby Medical, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN220028 | Cue COVID-19 Molecular Test | Cue Health, Inc. | 2023 | — |
| 0 (this device) | K253971 | Visby Medical Flu and COVID-19 Test | Visby Medical, Inc. | 2026 | — |
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 SIA? 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
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 |
|---|---|---|---|
| * | DEN220028 | Cue COVID-19 Molecular TestSummary page 5…sification: Class II Regulation: 21 CFR 866.3984 Primary Product Code: SIA C. Predicate Device Cue COVID-19 Molecular Test (DEN220028) D. Device Description The Visby Medical Flu and COVID-19 Test is a non-prescription, single-use (disposable),… | 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?
- Its one ancestor has no recall.
- 2 other devices also cite its predicate DEN220028.
How does its category compare?
All SIA devicesSIA Over-The-Counter Molecular Multi-Analyte Respiratory Virus Detection Test: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · SIA
1so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · SIA
Too few SIA 510(k)s in any year since 2007 to give a median.
Recalls per year · SIA
No recall names SIA since 2007.
Adverse event reports per year · SIA
No MAUDE report names SIA 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 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Visby Medical Flu and COVID-19 Test is a single-use (disposable), fully integrated, automated RT PCR in vitro diagnostic test intended for the qualitative detection and differentiation of influenza A, influenza B, and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral RNA in anterior nasal swab samples from individuals with signs and symptoms of a viral respiratory infection. Clinical signs and symptoms of respiratory viral infection…
Read the full statement (197 words)
The Visby Medical Flu and COVID-19 Test is a single-use (disposable), fully integrated, automated RT PCR in vitro diagnostic test intended for the qualitative detection and differentiation of influenza A, influenza B, and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral RNA in anterior nasal swab samples from individuals with signs and symptoms of a viral respiratory infection. Clinical signs and symptoms of respiratory viral infection due to SARS-CoV-2 and influenza can be similar. This test is intended for individuals aged 14 years or older testing themselves, or adults testing individuals aged 2 years or older.
All negative results are presumptive and should be confirmed with a lab-based molecular assay when determined to be appropriate by a healthcare provider. Negative results do not rule out infection with influenza, SARS-CoV-2 or other pathogens.
Individuals who test negative and experience continued or worsening respiratory symptoms such as fever, cough and/or shortness of breath should seek follow-up care with their healthcare provider.
Positive results do not rule out co-infection with other respiratory pathogens. This test is not a substitute for visits to a healthcare provider or appropriate follow-up and should not be used to determine any treatments without provider supervision.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253971 · printed Nov 4, 2026
Cite this page
510(k) Report. “K253971: Visby Medical Flu and COVID-19 Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K253971
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026