FDA product code MNW: Analyzer, Body Composition
MNW is the FDA product code for analyzer, body composition. It is a Class II device, regulated under 21 CFR 870.2770 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 79 510(k) submissions under MNW, 1 in the last five years, from 46 different applicants. The average 510(k) review took 191 days (median 141); 422 days on average over the last three years.
Classification
| Field | Value |
|---|---|
| Device name | Analyzer, Body Composition |
| Device class | Class II |
| Regulation | 21 CFR 870.2770 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
510(k) clearances per year for MNW
| Year | Clearances | Avg. review days |
|---|---|---|
| 2024 | 1 | 422 |
Compare with all 510(k) review times · Search every MNW clearance
Top MNW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Biospace Corporation Limited | 8 | 2014-09-23 |
| Bodystat , Ltd. | 7 | 2011-02-07 |
| Jawon Medical Co., Ltd. | 5 | 2015-02-18 |
| Zhongshan Transtek Electronics Co., Ltd. | 4 | 2013-01-09 |
| Omron Healthcare, Inc. | 4 | 2006-11-07 |
41 more applicants have MNW clearances. See the full list in Caduvo.
Most recent MNW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K231116 | Zhongshan Jinli Electronic Weighing Equipment Co., Ltd. | Multi-parameter detector | 2024-06-15 | 422 |
| K140045 | Jawon Medical Co., Ltd. | BODY COMPOSITION ANALYZER | 2015-02-18 | 406 |
| K141483 | Biospace Corporation Limited | BIOSPACE BODY COMPOSITION ANALYZER | 2014-09-23 | 110 |
| K133872 | Fitbit, Inc. | ARIA WIFI SMART SCALE | 2014-06-02 | 164 |
| K140594 | Conmo Electronic Company Limited | BODY FAT ANALYZER AND SCALE | 2014-05-30 | 84 |
Recalls for MNW devices
openFDA lists no recalls for product code MNW.
Frequently asked questions
What is FDA product code MNW?
MNW is the FDA product code for analyzer, body composition. It is a Class II device, regulated under 21 CFR 870.2770 and reviewed by the Gastroenterology and Urology panel.
What device class is MNW?
Class II, regulation 21 CFR 870.2770. Typical premarket route: 510(k).
How long does a 510(k) take for product code MNW?
Across 79 cleared submissions the average was 191 days from receipt to decision (median 141).
Which companies have the most MNW clearances?
Biospace Corporation Limited (8); Bodystat , Ltd. (7); Jawon Medical Co., Ltd. (5); Zhongshan Transtek Electronics Co., Ltd. (4); Omron Healthcare, Inc. (4).
Next steps
- Run an FDA pathway report with predicate devices for product code MNW
- Run a recall and safety report across every MNW manufacturer
- Watch product code MNW 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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