FDA Product Code DSI: Detector And Alarm, Arrhythmia
Leading manufacturers include Siemens Medical Solutions USA, Inc., Fukuda Denshi USA, Inc. and Nihon Kohden America, Inc..
398
Total
398
Cleared
150d
Avg days
1976
Since
Growing category -
3 submissions in the last 2 years
vs 2 in the prior period
Review times increasing: avg
302d
recently vs 149d historically
FDA 510(k) Cleared Detector And Alarm, Arrhythmia Devices (Product Code DSI)
398 devices
Cleared
Jan 23, 2026
BodyGuardian Remote Monitoring System (BGRMS v3.0)
Boston Scientific Cardiac Diagnostic Technologies, Inc.
Cardiovascular
452d
Cleared
Jul 29, 2025
MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)
Infobionic, Inc.
Cardiovascular
172d
Cleared
Oct 30, 2024
Zio AT® device (A100A1001)
iRhythm Technologies, Inc.
Cardiovascular
281d
Cleared
Oct 06, 2023
MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System
Infobionic, Inc.
Cardiovascular
248d
Cleared
Aug 30, 2023
SmartCardia 7L Platform
Smartcardia SA
Cardiovascular
120d
Cleared
Apr 09, 2020
Unified Arrhythmia Diagnostic System PocketECG IV
Medicalgorithmics S.A.
Cardiovascular
153d
Cleared
Mar 26, 2020
BodyGuardian Remote Monitoring System
Preventice Technologies, Inc.
Cardiovascular
181d
Cleared
Sep 24, 2019
Patient Assistant Model PA97000
Medtronic, Inc.
Cardiovascular
202d
Cleared
May 15, 2019
Liba3 System
National Cardiac, Inc.
Cardiovascular
243d
Cleared
Mar 26, 2019
MobileECG 2 BT
Memtec Corporation
Cardiovascular
274d
Cleared
Jul 11, 2018
Medicalgorithmics Unified Cardiac Rehabilitation System
Medicalgorithmics S.A.
Cardiovascular
194d
Cleared
Jan 10, 2018
Epicardia Anywhere
Medicomp, Inc.
Cardiovascular
103d
Cleared
Jul 17, 2015
IntelliVue Patient Monitor
Philips Medizin Systeme Boeblingen GmbH
Cardiovascular
25d
Cleared
May 27, 2015
Medtronic Patient Asistant
Medtronic, Inc.
Cardiovascular
127d
Cleared
May 13, 2015
IntelliVue Patient Monitor
Philips Medizin Systeme Boeblingen GmbH
Cardiovascular
93d
Cleared
Apr 10, 2012
ACUITY CENTRAL MONITORING STATION OR ACUITY CENTRAL MONITORING SYSTEM, MOBILE ACUITY LT, MOBILE ACUITY, MOBILE LT
Welch Allyn, Inc.
Cardiovascular
27d
Cleared
Nov 17, 2011
INTELLIVUE MX40 PATIENT MONITOR
Philips Medical Systems
Cardiovascular
24d
Cleared
May 04, 2011
REVEAL XT INSERTABLE CARDIAC MONITOR, MODEL 9529 AND REVEAL DX INSERTABLE CARDIAC MONITOR, MODEL 9528
Medtronic, Inc.
Cardiovascular
132d
Cleared
Apr 06, 2011
CG-5108 ACT-3L CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR
Card Guard Scientific Survival , Ltd.
Cardiovascular
43d
Cleared
Jul 13, 2010
MODIFICATION TO: CG-6108 ACT-3L CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR, MODEL FG-00084
Card Guard Scientific Survival , Ltd.
Cardiovascular
26d
Cleared
Jun 25, 2010
CG-6108 ACT-IL CONTINUOUS ECG MONITOR AND ARRYTHMIA DETECTOR
Card Guard Scientific Survival , Ltd.
Cardiovascular
15d
Cleared
Nov 07, 2008
REVEAL XT INSERTABLE CARDIAC MONITOR, MODEL 9529, REVEL DX INSERTABLE CARDIAC MONITOR, MODEL 9528
Medtronic, Inc.
Cardiovascular
71d
Cleared
May 29, 2008
CG-6108 ACT-3L CONTINUOUS ECG MONITOR & ARRHYTHMIA DETECTOR
Card Guard Scientific Survival , Ltd.
Cardiovascular
27d
Cleared
May 19, 2008
DATEX-OHMEDA S/5 CRITICAL CARE MONITOR WITH L-ICU05 AND L-ICU05A SOFTWARE
Ge Healthcare
Cardiovascular
315d
About Product Code DSI - Regulatory Context
510(k) Submission Activity
398 total 510(k) submissions under product code DSI since 1976, with 398 receiving FDA clearance (average review time: 150 days).
Submission volume has increased in recent years - 3 submissions in the last 24 months compared to 2 in the prior period - suggesting growing market activity in this device classification.
FDA 510(k) Review Time - DSI Product Code
Recent submissions under DSI have taken an average of 302 days to reach a decision - up from 149 days historically. Manufacturers should account for longer review timelines in current project planning.
DSI devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →