DSI · Class II · 21 CFR 870.1025

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
1–24 of 398
Cleared Jan 23, 2026
BodyGuardian Remote Monitoring System (BGRMS v3.0)
K243349
Boston Scientific Cardiac Diagnostic Technologies, Inc.
Cardiovascular · 452d
Cleared Jul 29, 2025
MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)
K250356
Infobionic, Inc.
Cardiovascular · 172d
Cleared Oct 30, 2024
Zio AT® device (A100A1001)
K240177
iRhythm Technologies, Inc.
Cardiovascular · 281d
Cleared Oct 06, 2023
MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System
K230265
Infobionic, Inc.
Cardiovascular · 248d
Cleared Aug 30, 2023
SmartCardia 7L Platform
K231276
Smartcardia SA
Cardiovascular · 120d
Cleared Apr 09, 2020
Unified Arrhythmia Diagnostic System PocketECG IV
K193104
Medicalgorithmics S.A.
Cardiovascular · 153d
Cleared Mar 26, 2020
BodyGuardian Remote Monitoring System
K192732
Preventice Technologies, Inc.
Cardiovascular · 181d
Cleared Sep 24, 2019
Patient Assistant Model PA97000
K190574
Medtronic, Inc.
Cardiovascular · 202d
Cleared May 15, 2019
Liba3 System
K182532
National Cardiac, Inc.
Cardiovascular · 243d
Cleared Mar 26, 2019
MobileECG 2 BT
K181658
Memtec Corporation
Cardiovascular · 274d
Cleared Jul 11, 2018
Medicalgorithmics Unified Cardiac Rehabilitation System
K173969
Medicalgorithmics S.A.
Cardiovascular · 194d
Cleared Jan 10, 2018
Epicardia Anywhere
K173170
Medicomp, Inc.
Cardiovascular · 103d
Cleared Jul 22, 2016
Braemar Telemetry Patch System
K153473
Braemar Manufacturing, LLC
Cardiovascular · 233d
Cleared May 25, 2016
EMMa Electronic Monitoring Management
K153477
Vitasystems GmbH
Cardiovascular · 175d
Cleared Apr 22, 2016
Matrix Mini ECG Monitor
K152701
Global Instrumentation, LLC
Cardiovascular · 214d
Cleared Apr 08, 2016
Nihon Kohden Afib Detection Program QP-039P
K152305
Nihon Kohden Corporation
Cardiovascular · 238d
Cleared Feb 05, 2016
Vital Signs Patch System
K151835
Lifewatch Technologies , Ltd.
Cardiovascular · 214d
Cleared Jan 15, 2016
ECG Mini System Continuous ECG Monitor and Arrhythmia Detector
K151269
Lifewatch Technologies , Ltd.
Cardiovascular · 247d
Cleared Dec 17, 2015
MoMe Software Platform
K152491
Infobionic, Inc.
Cardiovascular · 107d
Cleared Oct 08, 2015
MEDICALGORITHMICS UNIFIED ARRHYTHMIA DIAGNOSIC SYSTEM
K152550
Medicalgorithmics S.A.
Cardiovascular · 30d
Cleared Sep 17, 2015
BodyGuardian Remote Monitoring System
K151188
Preventice
Cardiovascular · 136d
Cleared Sep 11, 2015
CG-6108 ACT-3L Continuous ECG Monitor and Arrhythmia Detector
K143359
Lifewatch Technologies , Ltd.
Cardiovascular · 291d
Cleared Jul 17, 2015
IntelliVue Patient Monitor
K151681
Philips Medizin Systeme Boeblingen GmbH
Cardiovascular · 25d
Cleared May 27, 2015
Medtronic Patient Asistant
K150117
Medtronic, Inc.
Cardiovascular · 127d

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 →