Class Class II
Visby Medical Respiratory Health Test (K242526)
Description
Visby Medical Respiratory Health Test by Visby Medical, Inc., an FDA 510(k) cleared microbiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK242526
Clearance Date2025-02-19
Clearance TypeDual Track
Product CodeQOF
Regulation Number866.3981
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242526
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Visby Medical Respiratory Health Test (K242526) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K220963 | Simplexa COVID-19 & Flu A/B Direct | Diasorin Molecular, LLC | 2023 |
Trace the full predicate network for K242526
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.