FDA Product Code DXN: System, Measurement, Blood-pressure, Non-invasive
Under FDA product code DXN, non-invasive blood pressure measurement systems are cleared for clinical and ambulatory use.
These devices use oscillometric or auscultatory methods to measure systolic and diastolic blood pressure without arterial puncture. They range from bedside monitors to ambulatory devices that record pressure over 24-hour periods for hypertension diagnosis and management.
DXN devices are Class II medical devices, regulated under 21 CFR 870.1130 and reviewed by the FDA Cardiovascular panel.
Leading manufacturers include Joytech Healthcare Co. , Ltd., Guangdong Transtek Medical Electronics Co., Ltd. and Microlife Intellectual Property GmbH.
FDA 510(k) Cleared System, Measurement, Blood-pressure, Non-invasive Devices (Product Code DXN)
About Product Code DXN - Regulatory Context
510(k) Submission Activity
1210 total 510(k) submissions under product code DXN since 1976, with 1210 receiving FDA clearance (average review time: 137 days).
Submission volume has remained relatively stable over the observed period, with 51 submissions in the last 24 months.
FDA Review Time
FDA review times for DXN submissions have been consistent, averaging 144 days recently vs 137 days historically.
DXN devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →