DRM · Class II · 21 CFR 870.5200

FDA Product Code DRM: Compressor, Cardiac, External

Leading manufacturers include Defibtech, LLC and Zoll Circulation, Inc..

45
Total
45
Cleared
113d
Avg days
1976
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Compressor, Cardiac, External Devices (Product Code DRM)

45 devices
1–24 of 45
Cleared Mar 09, 2023
AutoPulse NXT Resuscitation System
K221700
Zoll Circulation, Inc.
Cardiovascular · 269d
Cleared Nov 09, 2021
RMU-2000 Automated Chest Compression System
K211289
Defibtech, LLC
Cardiovascular · 195d

About Product Code DRM - Regulatory Context

510(k) Submission Activity

45 total 510(k) submissions under product code DRM since 1976, with 45 receiving FDA clearance (average review time: 113 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.

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