FDA Product Code DSI: Detector And Alarm, Arrhythmia
Leading manufacturers include Siemens Medical Solutions USA, Inc., Hewlett-Packard Co. and Medtronic, 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
May 27, 2015
Medtronic Patient Asistant
Medtronic, Inc.
Cardiovascular
127d
Cleared
May 04, 2011
REVEAL XT INSERTABLE CARDIAC MONITOR, MODEL 9529 AND REVEAL DX INSERTABLE CARDIAC MONITOR, MODEL 9528
Medtronic, Inc.
Cardiovascular
132d
Cleared
Nov 07, 2008
REVEAL XT INSERTABLE CARDIAC MONITOR, MODEL 9529, REVEL DX INSERTABLE CARDIAC MONITOR, MODEL 9528
Medtronic, Inc.
Cardiovascular
71d
Cleared
Nov 21, 2007
REVEAL XT
Medtronic, Inc.
Cardiovascular
159d
Cleared
Nov 21, 2007
REVEAL DX INSERTABLE CARDIAC MONITOR, REVEAL PATIENT ASSISTANT, MODEL(S) 9528,9538
Medtronic, Inc.
Cardiovascular
156d
Cleared
Mar 23, 2004
SIEMENS KION ANESTHESIA WORKSTATION - EXTENDED MODES FUNCTIONALITY, MODELS: 64 62 910 E392E, 65 22 572 E397E, 65 03 655
Siemens Medical Solutions USA, Inc.
Cardiovascular
459d
Cleared
Aug 19, 2003
SIEMENS INFINITY MODULAR MONITORS, MODELS SC 7000, SC 9000XL AND SC 8000 WITH VF3 MODIFICATIONS
Siemens Medical Solutions USA, Inc.
Cardiovascular
105d
Cleared
Aug 17, 2001
SIEMENS INFINITY MIB II DUO PROTOCOL CONVERTER
Siemens Medical Solutions USA, Inc.
Cardiovascular
16d
Cleared
Dec 21, 2000
SIEMENS MULTI VIEW WORKSTATION WITH VENT VIEWER OPTION
Siemens Medical Solutions USA, Inc.
Cardiovascular
65d
Cleared
Nov 09, 2000
SIEMENS MULTIVIEW INFINITY TELEMETRY SYSTEM
Siemens Medical Solutions USA, Inc.
Cardiovascular
29d
Cleared
Nov 08, 1999
HP M2600A VIRIDIA TELEMETRY SYSTEM
Hewlett-Packard Co.
Cardiovascular
21d
Cleared
Oct 21, 1999
HP VIRIDIA INFORMATION SYSTEM, MODELS M3150A/ M3151A/ M3153A/ M3154A
Hewlett-Packard Co.
Cardiovascular
30d
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 →