PMA · Approved
ApprovedUroVysion Bladder Cancer Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Approved on Feb 18, 2026 through premarket approval, which rests on the device’s own clinical evidence after a 28-day review.
- Decided
- Feb 18, 2026
- Review
- 28 days
- Class
- Class III
- Recalls
- None
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in this category? 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?
PMA 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.
https://510kreport.com/device/P030052/S030 · printed Nov 6, 2026
Cite this page
510(k) Report. “P030052/S030: UroVysion Bladder Cancer Kit.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P030052/S030
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026