ClearanceBrief
Panels › Cardiovascular › Product code DSI · Class 2

Detector And Alarm, Arrhythmia

Regulation 870.1025

1510(k)s in 12 months (398 all time)
20recalls in 12 months (82 all time)
78recalls that name a 510(k)
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Top companies in DSI

Company510(k)sRecalls
Philips North America028
Siemens Medical Solutions USA, Inc.270
Hewlett-Packard Co.220
Fukuda Denshi USA, Inc.190
Nihon Kohden America, Inc.180
Spacelabs Healthcare, Inc.116
Spacelabs Medical, Inc.134
Oxford Medilog, Inc.140
Mennen Medical , Ltd.130
Marquette Electronics, Inc.110
Decided510(k)Device and applicantCode
Jan 23, 2026K243349BodyGuardian Remote Monitoring System (BGRMS v3.0)
Boston Scientific Cardiac Diagnostic Technologies, Inc.
DSI
Jul 29, 2025K250356MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)
Infobionic, Inc.
DSI
Oct 30, 2024K240177Zio AT® device (A100A1001)
iRhythm Technologies, Inc.
DSI
Oct 6, 2023K230265MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System
Infobionic, Inc.
DSI
Aug 30, 2023K231276SmartCardia 7L Platform
Smartcardia SA, CH
DSI
Apr 9, 2020K193104Unified Arrhythmia Diagnostic System PocketECG IV
Medicalgorithmics S.A., PL
DSI
Mar 26, 2020K192732BodyGuardian Remote Monitoring System
Preventice Technologies, Inc.
DSI
Sep 24, 2019K190574Patient Assistant Model PA97000
Medtronic, Inc.
DSI
May 15, 2019K182532Liba3 System
National Cardiac, Inc.
DSI
Mar 26, 2019K181658MobileECG 2 BT
Memtec Corporation
DSI
Jul 11, 2018K173969Medicalgorithmics Unified Cardiac Rehabilitation System
Medicalgorithmics S.A., PL
DSI
Jan 10, 2018K173170Epicardia Anywhere
Medicomp, Inc.
DSI
Jul 22, 2016K153473Braemar Telemetry Patch System
Braemar Manufacturing, LLC
DSI
May 25, 2016K153477EMMa Electronic Monitoring Management
Vitasystems GmbH, DE
DSI
Apr 22, 2016K152701Matrix Mini ECG Monitor
Global Instrumentation, LLC
DSI
Apr 8, 2016K152305Nihon Kohden Afib Detection Program QP-039P
Nihon Kohden Corporation, JP
DSI
Feb 5, 2016K151835Vital Signs Patch System
Lifewatch Technologies , Ltd., IL
DSI
Jan 15, 2016K151269ECG Mini System Continuous ECG Monitor and Arrhythmia Detector
Lifewatch Technologies , Ltd., IL
DSI
Dec 17, 2015K152491MoMe Software Platform
Infobionic, Inc.
DSI
Oct 8, 2015K152550MEDICALGORITHMICS UNIFIED ARRHYTHMIA DIAGNOSIC SYSTEM
Medicalgorithmics S.A., PL
DSI
Sep 17, 2015K151188BodyGuardian Remote Monitoring System
Preventice
DSI
Sep 11, 2015K143359CG-6108 ACT-3L Continuous ECG Monitor and Arrhythmia Detector
Lifewatch Technologies , Ltd., IL
DSI
Jul 17, 2015K151681IntelliVue Patient Monitor
Philips Medizin Systeme Boeblingen GmbH, DE
DSI
May 27, 2015K150117Medtronic Patient Asistant
Medtronic, Inc.
DSI
May 13, 2015K150310IntelliVue Patient Monitor
Philips Medizin Systeme Boeblingen GmbH, DE
DSI
Mar 12, 2015K142352CardiacLinx
Ross Medical Technology, Inc.
DSI
Jan 9, 2015K141441MENNTOR X7
Mennen Medical , Ltd., IL
DSI
Dec 19, 2014K132407VITAL SIGNS PATCH SYSTEM (IN SHORT VSP)
Lifewatch Technologies , Ltd., IL
DSI
Dec 12, 2014K142180TELESENSE
Scottcare Corporation
DSI
May 23, 2014K140548CORCAM HEART MONITOR
Corcam Technologia, SA
DSI
Jan 8, 2014K131000V-PATCH SYSTEM
Intelesens Limited
DSI
Feb 21, 2013K124060MEDICAL GORITHMICS UNIFIED ARRHYTHMIA DIAGNOSTIC SYSTEM
Medicalgorithmics S.A.
DSI
Aug 10, 2012K121197BODYGUARDIAN SYSTEM BODYGUARDIAN CONTROL UNIT BODYGUARDIAN CONNECT
Preventice, Inc.
DSI
May 16, 2012K112921MEDICALGORITHMICS UNIFIED ARRHYTHMIA DIAGNOSTIC SYSTEM
Medicalgorithmics S.A.
DSI
Apr 10, 2012K120774ACUITY CENTRAL MONITORING STATION OR ACUITY CENTRAL MONITORING SYSTEM, MOBILE ACUITY LT, MOBILE ACUITY, MOBILE LT
Welch Allyn, Inc.
DSI
Nov 17, 2011K113125INTELLIVUE MX40 PATIENT MONITOR
Philips Medical Systems
DSI
Aug 1, 2011K111160INTRICON DATRIX CENTAURI MT AMBULATORY PATIENT ECG TELEMETRY SYSTEM (APETS)
Intricon Datrix Corporation
DSI
Jun 13, 2011K102507AREA-CT, TZ MEDICAL MCOT ECG MONITOR AND ARRHYTHMIA DETECTOR
Tz Medical, Inc.
DSI
May 4, 2011K103764REVEAL XT INSERTABLE CARDIAC MONITOR, MODEL 9529 AND REVEAL DX INSERTABLE CARDIAC MONITOR, MODEL 9528
Medtronic, Inc.
DSI
Apr 6, 2011K110499CG-5108 ACT-3L CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR
Card Guard Scientific Survival , Ltd.
DSI
Mar 3, 2011K103142SPACELABS MULTI-PARAMETER MODULE
Spacelabs Healthcare, Inc.
DSI
Dec 7, 2010K102111MEDICAL MAGNETIC TAPE RECORDER
Wpr Medical AS
DSI
Jul 13, 2010K101703MODIFICATION TO: CG-6108 ACT-3L CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR, MODEL FG-00084
Card Guard Scientific Survival , Ltd.
DSI
Jun 25, 2010K101639CG-6108 ACT-IL CONTINUOUS ECG MONITOR AND ARRYTHMIA DETECTOR
Card Guard Scientific Survival , Ltd.
DSI
May 7, 2010K093766VITALOGIK 6000/6500
Mennen Medical , Ltd., IL
DSI
Apr 20, 2010K100155TRUVUE WIRELESS AMBULATORY ECG MONITORING SYSTEM
Biomedical Systems Corp.
DSI
Feb 26, 2010K092947TELESENTRY, MODEL TS01
Scottcare Corporation
DSI
Nov 3, 2009K091927INTELLIVUE PATIENT MONITORS ,MODELS MP40, MP50, MP60, MP70, MP80, MP90
Philips Medizinsysteme Boeblingen GmbH, Cardiac AN, DE
DSI
Aug 27, 2009K091971AVIVO MOBILE PATIENT MANAGEMENT SYSTEM, NUVANT MOBILE CARDIAC TELEMETRY (MCT) SYSTEM
Corventis, Inc.
DSI
May 22, 2009K090037MEDICALGORITHMICS REAL-TIME ECG MONITOR AND ARRHYTHMIA DETECTOR, MODEL POCKETECG
Medicalgorithmics SP Z.O.O.
DSI

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