FDA Product Code DXR: Ballistocardiograph

510(k) Submission Activity

5 total 510(k) submissions under product code DXR since 1987, with 5 receiving FDA clearance (average review time: 251 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA Review Time

FDA review times for DXR submissions have been consistent, averaging 246 days recently vs 253 days historically.