FDA product code KZM: Device, Muscle Monitoring
KZM is the FDA product code for device, muscle monitoring. It is a Class II device, regulated under 21 CFR 890.1375 and reviewed by the Dental panel. FDA has cleared 19 510(k) submissions under KZM, from 11 different applicants. The average 510(k) review took 215 days (median 137).
Classification
| Field | Value |
|---|---|
| Device name | Device, Muscle Monitoring |
| Device class | Class II |
| Regulation | 21 CFR 890.1375 |
| Review panel | DE — Dental |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every KZM clearance
Top KZM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Bio-Research Associates, Inc. | 5 | 2013-07-25 |
| Myo-Tronics, Inc. | 3 | 1994-12-09 |
| Myotronics-Noromed, Inc. | 2 | 2000-11-06 |
| Myo-Tronics Research, Inc. | 2 | 1983-02-09 |
| Bts S.P.A. | 1 | 2016-12-21 |
6 more applicants have KZM clearances. See the full list in Caduvo.
Most recent KZM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K161716 | Bts S.P.A. | TEETHAN 2.0 | 2016-12-21 | 183 |
| K130158 | Bio-Research Associates, Inc. | M-SCAN | 2013-07-25 | 183 |
| K113677 | Medotech A/S | GRINDCARE MEASURE | 2012-04-05 | 113 |
| K082927 | Bio-Research Associates, Inc. | BIOEMG III | 2009-02-06 | 128 |
| K043373 | Neuromuscular Technologies, Inc. | DOLOTENS DENTAL TM 1 | 2005-09-02 | 268 |
Recalls for KZM devices
openFDA lists no recalls for product code KZM.
Frequently asked questions
What is FDA product code KZM?
KZM is the FDA product code for device, muscle monitoring. It is a Class II device, regulated under 21 CFR 890.1375 and reviewed by the Dental panel.
What device class is KZM?
Class II, regulation 21 CFR 890.1375. Typical premarket route: 510(k).
How long does a 510(k) take for product code KZM?
Across 19 cleared submissions the average was 215 days from receipt to decision (median 137).
Which companies have the most KZM clearances?
Bio-Research Associates, Inc. (5); Myo-Tronics, Inc. (3); Myotronics-Noromed, Inc. (2); Myo-Tronics Research, Inc. (2); Bts S.P.A. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KZM
- Run a recall and safety report across every KZM manufacturer
- Watch product code KZM 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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