510(k) · Cleared
Recalled · 2004Vysis Urovysion Bladder Cancer Recurrence Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vysis · MMW System, Test, Tumor Marker, Monitoring, Bladder
Cleared on Aug 3, 2001 after a 120-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 8 later devices descend from it. It has been recalled once.
- Decided
- Aug 3, 2001
- Review
- 120 days
- Class
- Class II
- Product code
- MMW
- Recalls
- 1
- Predicates
- 0
8 later devices descend from it, 1 citing it directly.
- This deviceK011031 Vysis Urovysion Bladder Cancer Recurrence KitVysis · 2001
- Descendant · cites it directly · 7 of its ownK050840 Modification to Duet SystemBioview, Ltd. · 2005
- Descendant · 2 generations on · 5 of its ownK061602 Duet SystemBioview, Ltd. · 2007
- Descendant · 3 generations on · 2 of its ownK101291 Scanview HER2/Neu Fish SystemApplied Spectral Imaging, Ltd. · 2010
- Descendant · 2 generations on · 1 of its ownK110345 Scanview SystemApplied Spectral Imaging · 2011
- Descendant · 2 generations on · 0 of its ownK130775 Duet SystemBioview, Ltd. · 2014
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K050840Modification to Duet SystemBioview, Ltd. · 2005 · cites it directly7descendants
- K061602Duet SystemBioview, Ltd. · 2007 · 2 generations on5descendants
- K101291Scanview HER2/Neu Fish SystemApplied Spectral Imaging, Ltd. · 2010 · 3 generations on2descendants
- K110345Scanview SystemApplied Spectral Imaging · 2011 · 2 generations on1descendant
- K130775Duet SystemBioview, Ltd. · 2014 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K011031 | Vysis Urovysion Bladder Cancer Recurrence Kit | Vysis | 2001 | — |
| +1 | K050840 | Modification to Duet System | Bioview, Ltd. | 2005 | — |
| +2 | K061602 | Duet System | Bioview, Ltd. | 2007 | — |
| +3 | K101291 | Scanview HER2/Neu Fish System | Applied Spectral Imaging, Ltd. | 2010 | — |
| +2 | K110345 | Scanview System | Applied Spectral Imaging | 2011 | — |
| +2 | K130775 | Duet System | Bioview, Ltd. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MMW? 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 MMW device
- #1 K203245 Bladder EpiCheck DNA extraction kit…score 5.3 · 1 generation · no Class I recall
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K050840 | Modification to Duet System | 2005 | 7 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 19, 2004 | Not classified | Z-0640-04 | Other | Some of the control slides did not have adequate cells deposited upon their surface. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K050840 (Bioview, Ltd., 2005) has gone furthest, with 7 descendants of its own.
How does its category compare?
All MMW devicesMMW System, Test, Tumor Marker, Monitoring, Bladder: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MMW
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · MMW
Too few MMW 510(k)s in any year since 2007 to give a median.
Recalls per year · MMW
No recall names MMW since 2007.
Adverse event reports per year · MMW
1in 2013
MAUDE reports naming product code MMW, 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 | 1 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 3 |
| 2013 | 0 | — | 0 | 1 |
| 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 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K011031 · printed Nov 6, 2026
Cite this page
510(k) Report. “K011031: Vysis Urovysion Bladder Cancer Recurrence Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011031
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026