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 Howmedica Corp., Hewlett-Packard Co. and Unimed Medical Supplies, Inc..
FDA 510(k) Cleared Blood Pressure Cuff Devices (Product Code DXQ)
About Product Code DXQ - Regulatory Context
510(k) Submission Activity
198 total 510(k) submissions under product code DXQ since 1976, with 198 receiving FDA clearance (average review time: 99 days).
Submission volume has declined in recent years - 7 submissions in the last 24 months compared to 9 in the prior period.
FDA 510(k) Review Time - DXQ Product Code
FDA review times for DXQ submissions have been consistent, averaging 109 days recently vs 99 days historically.
DXQ devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →