FDA Product Code DPS: Electrocardiograph
FDA product code DPS covers electrocardiographs used for recording the electrical activity of the heart.
These devices capture and display the cardiac electrical cycle as a series of waveforms — P, QRS, and T waves — that provide diagnostic information about heart rate, rhythm, and conduction. ECG recordings are essential in the diagnosis of arrhythmias, myocardial infarction, and other cardiac conditions.
DPS devices are Class II medical devices, regulated under 21 CFR 870.2340 and reviewed by the FDA Cardiovascular panel.
Leading manufacturers include Masimo Corporation, Ge Medical Systems Information Technologies, Inc. and Edan Instruments, Inc..
FDA 510(k) Cleared Electrocardiograph Devices (Product Code DPS)
About Product Code DPS - Regulatory Context
510(k) Submission Activity
575 total 510(k) submissions under product code DPS since 1976, with 575 receiving FDA clearance (average review time: 136 days).
Submission volume has remained relatively stable over the observed period, with 13 submissions in the last 24 months.
FDA Review Time
Recent submissions under DPS have taken an average of 225 days to reach a decision - up from 134 days historically. Manufacturers should account for longer review timelines in current project planning.
DPS devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →