DRG · Class II · 21 CFR 870.2910

FDA Product Code DRG: Transmitters And Receivers, Physiological Signal, Radiofrequency

Leading manufacturers include Vitalconnect, Inc., Lifesignals, Inc. and Biointellisense, Inc..

191
Total
191
Cleared
127d
Avg days
1977
Since
Declining activity - 6 submissions in the last 2 years vs 8 in the prior period
Consistent review times: 125d avg (recent)

FDA 510(k) Cleared Transmitters And Receivers, Physiological Signal, Radiofrequency Devices (Product Code DRG)

191 devices
1–24 of 191
Cleared Jan 22, 2026
Perin Health System (PHD80060-2)
K252984
Perin Health Devices, LLC
Cardiovascular · 126d
Cleared Oct 02, 2025
EasyTeleMed (2.0.2)
K252440
Ingeniars S.R.L.
Cardiovascular · 59d
Cleared Jun 04, 2025
TeleRehab Aermos Cardiopulmonary Rehabilitation
K250259
The ScottCare Corporation
Cardiovascular · 127d
Cleared May 16, 2025
iBSM
K243837
Iorbit Digital Technologies Private Limited
Cardiovascular · 154d
Cleared Nov 12, 2024
UbiqVue™ 2A Multi-parameter System (UX2550)
K242018
Lifesignals, Inc.
Cardiovascular · 125d
Cleared Sep 26, 2024
BioButton System
K241101
Biointellisense, Inc.
Cardiovascular · 157d
Cleared Jun 03, 2024
ANNE Chest
K240251
Sibel Health, Inc.
Cardiovascular · 125d
Cleared Aug 10, 2023
ANNE One
K223711
Sibel Health, Inc.
Cardiovascular · 241d
Cleared May 15, 2023
HD+12, HD+15
K220526
Cardioline S.P.A
Cardiovascular · 445d
Cleared Mar 17, 2023
Alio
K223073
Alio, Inc.
Gastroenterology & Urology · 168d
Cleared Feb 06, 2023
Care Team Portal
K222398
Vivify Health, Inc.
Cardiovascular · 182d
Cleared Dec 12, 2022
BioButton System
K212957
Biolntellisense, Inc.
Cardiovascular · 452d
Cleared Nov 22, 2022
ANNE Pediatric
K221530
Sibel, Inc.
Cardiovascular · 180d
Cleared Jul 15, 2022
ers2 - ergoline Rehabilitation System
K212883
Ergoline GmbH
Cardiovascular · 308d
Cleared Jun 23, 2022
EZYPRO ECG Recorder (Model: UG02)
K213233
Sigknow Biomedical Co., Ltd.
Cardiovascular · 266d
Cleared Mar 24, 2022
Alio Medical Remote Monitoring System
K211365
Graftworx, Inc. Dba Alio
Cardiovascular · 324d
Cleared Feb 03, 2022
LifePath Remote Patient Monitoring Platform
K211822
Elastic Care Incorporated
Cardiovascular · 234d
Cleared Sep 14, 2021
ANNE One
K211305
Sibel, Inc.
Cardiovascular · 138d
Cleared Jul 21, 2021
LifeSignals Multi-Parameter Remote Monitoring Platform
K202868
Lifesignals, Inc.
Cardiovascular · 296d
Cleared Jul 15, 2020
LifeSignals ECG Remote Monitoring Patch Platform
K200690
Lifesignals, Inc.
Cardiovascular · 121d
Cleared Jun 01, 2020
Vitls Platform
K191620
Vitls, Inc.
Cardiovascular · 349d
Cleared Apr 20, 2020
Vista Solution Monitoring Kit, Vista Solution 2 10-day Evaluation Kit, VistaTablet 2 (Boxed)
K193343
Vitalconnect, Inc.
Cardiovascular · 139d
Cleared Apr 16, 2020
Philips Biosensor BX100
K192875
Philips Medical Systems
Cardiovascular · 191d
Cleared Feb 06, 2020
VitalPatch 5D Biosensor - single, VitalPatch 7D Biosensor - single, VitalPatch 5D Biosensor – bag of 20, VitalPatch 7D Biosensor – bag of 20
K192757
Vitalconnect, Inc.
Cardiovascular · 129d

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 declined in recent years - 6 submissions in the last 24 months compared to 8 in the prior period.

FDA 510(k) Review Time - DRG Product Code

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 →