# K021231: NMP22 Bladderchek Kit, NMP22 Control Kit

- Pathway: 510(k) (Traditional)
- Applicant: Matritech, Inc.
- Decided: Jul 30, 2002 after 103 days
- Product code: MMW (System, Test, Tumor Marker, Monitoring, Bladder)
- Device class: 2
- Regulation: 21 CFR 866.6010
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) BTA Stat: named in the summary without a submission number

## Indications for use
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.

Source page: https://510kreport.com/device/K021231
Methodology: https://510kreport.com/methodology