FDA Product Code BTA: Pump, Portable, Aspiration (manual Or Powered)

510(k) Submission Activity

155 total 510(k) submissions under product code BTA since 1979, with 155 receiving FDA clearance (average review time: 110 days).

Submission volume has increased in recent years - 11 submissions in the last 24 months compared to 9 in the prior period - suggesting growing market activity in this device classification.

FDA Review Time

FDA review times for BTA submissions have been consistent, averaging 113 days recently vs 109 days historically.