FDA Product Code DXQ: Blood Pressure Cuff
Blood pressure measurement depends on accurate, well-fitting cuffs. FDA product code DXQ covers blood pressure cuffs used with sphygmomanometers for indirect blood pressure measurement.
These inflatable cuffs are wrapped around the arm or thigh and inflated to occlude the brachial or popliteal artery, with controlled deflation allowing assessment of systolic and diastolic pressure. Correct cuff sizing is critical to measurement accuracy.
DXQ devices are Class II medical devices, regulated under 21 CFR 870.1120 and reviewed by the FDA Cardiovascular panel.
Leading manufacturers include Unimed Medical Supplies, Inc., Baxter Healthcare Corporation and Shenzhen Best Electronics Co., Ltd..
FDA 510(k) Cleared Blood Pressure Cuff Devices (Product Code DXQ)
About Product Code DXQ - Regulatory Context
510(k) Submission Activity
197 total 510(k) submissions under product code DXQ since 1976, with 197 receiving FDA clearance (average review time: 99 days).
Submission volume has declined in recent years - 6 submissions in the last 24 months compared to 10 in the prior period.
FDA Review Time
Recent submissions under DXQ have taken an average of 117 days to reach a decision - up from 99 days historically. Manufacturers should account for longer review timelines in current project planning.
DXQ devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →