510(k) · Cleared
ClearedModification to Vysis Urovysion Bladder Cancer Recurrence Test
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 Jan 22, 2004 after a 30-day review. The FDA summary names its predicate without a number. 8 later devices descend from it.
- Decided
- Jan 22, 2004
- Review
- 30 days
- Class
- Class II
- Product code
- MMW
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 1 citing it directly.
- This deviceK033982 Modification to Vysis Urovysion Bladder Cancer Recurrence TestVysis · 2004
- 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) | K033982 | Modification to Vysis Urovysion Bladder Cancer Recurrence Test | Vysis | 2004 | — |
| +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), 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 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? (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 |
|---|---|---|---|
| * | — | Bard® (Bion) BTAstat™ Test Named without a submission number |
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)
No FDA recall names this device.
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 | — |
What is it indicated for?
The UroVysion Bladder Cancer Recurrence Kit (UroVysion Kit) is designed to
detect aneuploidy for chromosomes 3, 7, 17, and loss of the 9p21 locus via
fluorescence in situ hybridization (FISH) in urine specimens from subjects with
transitional cell carcinoma of the bladder. Results from the UroVysion Kit are
intended for use as a noninvasive method for monitoring for tumor recurrence in
conjunction with cystoscopy in patients previously diagnosed with bladder cancer.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033982 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033982: Modification to Vysis Urovysion Bladder Cancer Recurrence Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033982
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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