FDA Product Code DRG: Transmitters And Receivers, Physiological Signal, Radiofrequency
Leading manufacturers include Sibel Health, Inc., Biointellisense, Inc. and Lifesignals, Inc..
191
Total
191
Cleared
127d
Avg days
1977
Since
Stable submission activity - 7 submissions in the last 2 years
Consistent review times:
125d avg (recent)
FDA 510(k) Cleared Transmitters And Receivers, Physiological Signal, Radiofrequency Devices (Product Code DRG)
191 devices
Cleared
Jan 22, 2026
Perin Health System (PHD80060-2)
Perin Health Devices, LLC
Cardiovascular
126d
Cleared
Oct 02, 2025
EasyTeleMed (2.0.2)
Ingeniars S.R.L.
Cardiovascular
59d
Cleared
Jun 04, 2025
TeleRehab Aermos Cardiopulmonary Rehabilitation
The ScottCare Corporation
Cardiovascular
127d
Cleared
May 16, 2025
iBSM
Iorbit Digital Technologies Private Limited
Cardiovascular
154d
Cleared
Nov 12, 2024
UbiqVue™ 2A Multi-parameter System (UX2550)
Lifesignals, Inc.
Cardiovascular
125d
Cleared
Sep 26, 2024
BioButton System
Biointellisense, Inc.
Cardiovascular
157d
Cleared
Jun 03, 2024
ANNE Chest
Sibel Health, Inc.
Cardiovascular
125d
About Product Code DRG - Regulatory Context
510(k) Submission Activity
191 total 510(k) submissions under product code DRG since 1977, with 191 receiving FDA clearance (average review time: 127 days).
Submission volume has remained relatively stable over the observed period, with 7 submissions in the last 24 months.
FDA Review Time
FDA review times for DRG submissions have been consistent, averaging 125 days recently vs 127 days historically.
DRG devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →