FDA Product Code DQK: Computer, Diagnostic, Programmable
FDA product code DQK covers programmable diagnostic computers used in cardiovascular medicine.
These systems acquire, process, and analyze cardiovascular signals — including ECG, hemodynamic data, and intracardiac electrograms — to support diagnosis and treatment decisions. They are used in cardiac catheterization labs, electrophysiology suites, and intensive care units.
DQK devices are Class II medical devices, regulated under 21 CFR 870.1425 and reviewed by the FDA Cardiovascular panel.
Leading manufacturers include Abbott Medical, Edwards Lifesciences, LLC and Biosense Webster, Inc..
FDA 510(k) Cleared Computer, Diagnostic, Programmable Devices (Product Code DQK)
About Product Code DQK - Regulatory Context
510(k) Submission Activity
427 total 510(k) submissions under product code DQK since 1976, with 427 receiving FDA clearance (average review time: 140 days).
Submission volume has remained relatively stable over the observed period, with 43 submissions in the last 24 months.
FDA Review Time
Recent submissions under DQK have taken an average of 119 days to reach a decision - down from 143 days historically, suggesting improved FDA processing for this classification.
DQK devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →