MNW · Class II · 21 CFR 870.2770

FDA Product Code MNW: Analyzer, Body Composition

Leading manufacturers include Zhongshan Jinli Electronic Weighing? Equipment Co., Ltd..

79
Total
79
Cleared
191d
Avg days
1997
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Review times increasing: avg 422d recently vs 188d historically

FDA 510(k) Cleared Analyzer, Body Composition Devices (Product Code MNW)

79 devices
1–24 of 79

About Product Code MNW - Regulatory Context

510(k) Submission Activity

79 total 510(k) submissions under product code MNW since 1997, with 79 receiving FDA clearance (average review time: 191 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA Review Time

Recent submissions under MNW have taken an average of 422 days to reach a decision - up from 188 days historically. Manufacturers should account for longer review timelines in current project planning.

MNW devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →