FDA product code MMW: System, Test, Tumor Marker, Monitoring, Bladder
MMW is the FDA product code for system, test, tumor marker, monitoring, bladder. It is a Class II device, regulated under 21 CFR 866.6010 and reviewed by the Immunology panel. FDA has cleared 9 510(k) submissions under MMW, 1 in the last five years, from 5 different applicants. The average 510(k) review took 251 days (median 120). FDA has posted 1 recall for MMW devices.
Classification
| Field | Value |
|---|---|
| Device name | System, Test, Tumor Marker, Monitoring, Bladder |
| Device class | Class II |
| Regulation | 21 CFR 866.6010 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for MMW
| Year | Clearances | Avg. review days |
|---|---|---|
| 2023 | 1 | 912 |
Compare with all 510(k) review times · Search every MMW clearance
Top MMW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Vysis | 3 | 2004-01-22 |
| Bard Diagnostic Sciences,Inc. | 3 | 1998-12-08 |
| Nucleix , Ltd. | 1 | 2023-05-04 |
| Matritech, Inc. | 1 | 2002-07-30 |
| Perimmune, Inc. | 1 | 1997-04-30 |
Most recent MMW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K203245 | Nucleix , Ltd. | Bladder EpiCheck DNA extraction kit, NX899090-01C, Bladder EpiCheck test kit, NX899090-02C, Bladder EpiCheck Software, NX899090-03C | 2023-05-04 | 912 |
| K033982 | Vysis | MODIFICATION TO VYSIS UROVYSION BLADDER CANCER RECURRENCE TEST | 2004-01-22 | 30 |
| K021231 | Matritech, Inc. | NMP22 BLADDERCHEK KIT, NMP22 CONTROL KIT | 2002-07-30 | 103 |
| K013785 | Vysis | UROVYSION BLADDER CANCER RECURRENCE KIT | 2002-02-08 | 86 |
| K011031 | Vysis | VYSIS UROVYSION BLADDER CANCER RECURRENCE KIT | 2001-08-03 | 120 |
Recalls for MMW devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2004-02-19.
Frequently asked questions
What is FDA product code MMW?
MMW is the FDA product code for system, test, tumor marker, monitoring, bladder. It is a Class II device, regulated under 21 CFR 866.6010 and reviewed by the Immunology panel.
What device class is MMW?
Class II, regulation 21 CFR 866.6010. Typical premarket route: 510(k).
How long does a 510(k) take for product code MMW?
Across 9 cleared submissions the average was 251 days from receipt to decision (median 120).
Which companies have the most MMW clearances?
Vysis (3); Bard Diagnostic Sciences,Inc. (3); Nucleix , Ltd. (1); Matritech, Inc. (1); Perimmune, Inc. (1).
Have MMW devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2004-02-19.
Next steps
- Run an FDA pathway report with predicate devices for product code MMW
- Run a recall and safety report across every MMW manufacturer
- Watch product code MMW for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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