FDA Product Code MLO: Electrocardiograph, Ambulatory, With Analysis Algorithm

FDA 510(k) Cleared Electrocardiograph, Ambulatory, With Analysis Algorithm Devices (Product Code MLO)

About Product Code MLO - Regulatory Context

510(k) Submission Activity

32 total 510(k) submissions under product code MLO since 1999, with 32 receiving FDA clearance (average review time: 195 days).

Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - MLO Product Code

Recent submissions under MLO have taken an average of 249 days to reach a decision - up from 191 days historically. Manufacturers should account for longer review timelines in current project planning.

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

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