510(k) · Cleared
ClearedNMP22 Bladderchek Kit, NMP22 Control Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Matritech, Inc. · MMW System, Test, Tumor Marker, Monitoring, Bladder
Cleared on Jul 30, 2002 after a 103-day review. The FDA summary names its predicate without a number.
- Decided
- Jul 30, 2002
- Review
- 103 days
- Class
- Class II
- Product code
- MMW
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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 |
|---|---|---|---|
| * | — | BTA Stat Named without a submission number |
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.
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 NMP22 BladderChek test is indicated for use as an aid in monitoring
bladder cancer patients, by professional and prescription home use, in
conjunction with standard diagnostic procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021231 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021231: NMP22 Bladderchek Kit, NMP22 Control Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021231
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026