DRN · Class II · 21 CFR 870.5225

FDA Product Code DRN: Device, Counter-pulsating, External

Leading manufacturers include Pression, Inc..

34
Total
34
Cleared
165d
Avg days
1980
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Review times increasing: avg 285d recently vs 162d historically

FDA 510(k) Cleared Device, Counter-pulsating, External Devices (Product Code DRN)

34 devices
1–24 of 34
Cleared Dec 22, 2025
Pression Wave PRO External Counter-Pulsation System
K250756
Pression, Inc.
Cardiovascular · 285d

About Product Code DRN - Regulatory Context

510(k) Submission Activity

34 total 510(k) submissions under product code DRN since 1980, with 34 receiving FDA clearance (average review time: 165 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

Recent submissions under DRN have taken an average of 285 days to reach a decision - up from 162 days historically. Manufacturers should account for longer review timelines in current project planning.

DRN devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →