Product code DSI— Cardiovascular
SIEMENS SC9000/SC9015 BEDSIDE MONITORING SYSTEM
- Classification name
- Detector And Alarm, Arrhythmia
- Device class
- Class 2
- Regulation
- 21 CFR 870.1025
- Advisory panel
- Cardiovascular
- Total cleared
- 398
- First cleared
- Most recent
Market context for product code DSI
FDA has cleared devices under product code DSI between 1976 and 2026, filed by 143 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2026
- 2025
- 2024
- 2023
- 2020
- 2019
- 2018
- 2016
- 2015
- 2014
- 2013
- 2012
- 2011
- 2010
- 2009
Top applicants under product code DSI
Adverse events under product code DSI
product code DSI- Death
- 170
- Injury
- 729
- Malfunction
- 10,680
- Total
- 11,579
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code DSI
1–100 of 398- K243349 — BodyGuardian Remote Monitoring System (BGRMS v3.0)
- K250356 — MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)
- K240177 — Zio AT® device (A100A1001)
- K230265 — MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System
- K231276 — SmartCardia 7L Platform
- K193104 — Unified Arrhythmia Diagnostic System PocketECG IV
- K192732 — BodyGuardian Remote Monitoring System
- K190574 — Patient Assistant Model PA97000
- K182532 — Liba3 System
- K181658 — MobileECG 2 BT
- K173969 — Medicalgorithmics Unified Cardiac Rehabilitation System
- K173170 — Epicardia Anywhere
- K153473 — Braemar Telemetry Patch System
- K153477 — EMMa Electronic Monitoring Management
- K152701 — Matrix Mini ECG Monitor
- K152305 — Nihon Kohden Afib Detection Program QP-039P
- K151835 — Vital Signs Patch System
- K151269 — ECG Mini System Continuous ECG Monitor and Arrhythmia Detector
- K152491 — MoMe Software Platform
- K152550 — MEDICALGORITHMICS UNIFIED ARRHYTHMIA DIAGNOSIC SYSTEM
- K151188 — BodyGuardian Remote Monitoring System
- K143359 — CG-6108 ACT-3L Continuous ECG Monitor and Arrhythmia Detector
- K151681 — IntelliVue Patient Monitor
- K150117 — Medtronic Patient Asistant
- K150310 — IntelliVue Patient Monitor
- K142352 — CardiacLinx
- K141441 — MENNTOR X7
- K132407 — VITAL SIGNS PATCH SYSTEM (IN SHORT VSP)
- K142180 — TELESENSE
- K140548 — CORCAM HEART MONITOR
- K131000 — V-PATCH SYSTEM
- K124060 — MEDICAL GORITHMICS UNIFIED ARRHYTHMIA DIAGNOSTIC SYSTEM
- K121197 — BODYGUARDIAN SYSTEM BODYGUARDIAN CONTROL UNIT BODYGUARDIAN CONNECT
- K112921 — MEDICALGORITHMICS UNIFIED ARRHYTHMIA DIAGNOSTIC SYSTEM
- K120774 — ACUITY CENTRAL MONITORING STATION OR ACUITY CENTRAL MONITORING SYSTEM, MOBILE ACUITY LT, MOBILE ACUITY, MOBILE LT
- K113125 — INTELLIVUE MX40 PATIENT MONITOR
- K111160 — INTRICON DATRIX CENTAURI MT AMBULATORY PATIENT ECG TELEMETRY SYSTEM (APETS)
- K102507 — AREA-CT, TZ MEDICAL MCOT ECG MONITOR AND ARRHYTHMIA DETECTOR
- K103764 — REVEAL XT INSERTABLE CARDIAC MONITOR, MODEL 9529 AND REVEAL DX INSERTABLE CARDIAC MONITOR, MODEL 9528
- K110499 — CG-5108 ACT-3L CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR
- K103142 — SPACELABS MULTI-PARAMETER MODULE
- K102111 — MEDICAL MAGNETIC TAPE RECORDER
- K101703 — MODIFICATION TO: CG-6108 ACT-3L CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR, MODEL FG-00084
- K101639 — CG-6108 ACT-IL CONTINUOUS ECG MONITOR AND ARRYTHMIA DETECTOR
- K093766 — VITALOGIK 6000/6500
- K100155 — TRUVUE WIRELESS AMBULATORY ECG MONITORING SYSTEM
- K092947 — TELESENTRY, MODEL TS01
- K091927 — INTELLIVUE PATIENT MONITORS ,MODELS MP40, MP50, MP60, MP70, MP80, MP90
- K091971 — AVIVO MOBILE PATIENT MANAGEMENT SYSTEM, NUVANT MOBILE CARDIAC TELEMETRY (MCT) SYSTEM
- K090037 — MEDICALGORITHMICS REAL-TIME ECG MONITOR AND ARRHYTHMIA DETECTOR, MODEL POCKETECG
- K090834 — EPICARDIA 5000
- K083287 — AVIVO MOBILE PATIENT MANAGEMENT SYSTEM
- K083517 — INTELLIVUE PATIENT MONITOR, MODELS MP2, MP5, MP20, MP30, MP40, MP50, MO60, MP7-, MP80, AND MP90
- K082475 — REVEAL XT INSERTABLE CARDIAC MONITOR, MODEL 9529, REVEL DX INSERTABLE CARDIAC MONITOR, MODEL 9528
- K082633 — INTELLIVUE PATIENT MONITOR, INTELLIVUE XDS, MODELS MP2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90
- K081444 — BRAEMAR FUSION WIRELESS - AMBULATORY ECG ARRHYTHMIA MONITORING SYSTEM
- K081257 — CG-6108 ACT-3L CONTINUOUS ECG MONITOR & ARRHYTHMIA DETECTOR
- K071889 — DATEX-OHMEDA S/5 CRITICAL CARE MONITOR WITH L-ICU05 AND L-ICU05A SOFTWARE
- K071995 — CG-6108 CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR
- K071641 — REVEAL XT; INSERTABLE CARDIAC MONITOR (MODEL 9529), PATIENT ASSISTANT (MODEL 9539)
- K071655 — REVEAL DX INSERTABLE CARDIAC MONITOR, REVEAL PATIENT ASSISTANT, MODEL(S) 9528,9538
- K073140 — VITALOGIK MODEL 4000/4500
- K071805 — NETGUARD AUTOMATED CLINICIAN ALERT SYSTEM, MODEL 0998-00-1600-XX
- K062976 — MODIFICATION TO CIC PRO CLINICAL INFORMATION CENTER
- K070260 — STAR ST AND ARRHYTHMIA SOFTWARE, RELEASE H.0
- K053263 — CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1003
- K052288 — VITALOGIK
- K052160 — ACUITY CENTRAL STATION, MODEL 020XXXXX (NOTE: XXXXX = VARIOUS CONFIG.)
- K050919 — LIFEGARD II FAMILY MULTI-FUNCTION PATIENT MONITOR, MODELS AN4320, AN4320P, AN4321P, AN4322P & AN3423P
- K050605 — SPACELABS MEDICAL MULTIPARAMETER MODULE 91496
- K050175 — SPACELABS MEDICAL MULTIPARAMETER MODULE 91496
- K024213 — SIEMENS KION ANESTHESIA WORKSTATION - EXTENDED MODES FUNCTIONALITY, MODELS: 64 62 910 E392E, 65 22 572 E397E, 65 03 655
- K033305 — INFINITY MULTIVIEW INFINITY TELEMETRY SYSTEM
- K032858 — THE PHILIPS INTELLIVUE MP40, MP50, MP60, MP70,AND MP90 PATIENT MONITORS, RELEASE B.O.
- K031433 — SIEMENS INFINITY MODULAR MONITORS, MODELS SC 7000, SC 9000XL AND SC 8000 WITH VF3 MODIFICATIONS
- K032370 — CIC PRO CLINICAL INFORMATION CENTER CENTRAL STATION
- K023798 — MODIFICATION TO ENVOY PATIENT MONITOR
- K020550 — PASSPORT 2 WITH VIEW 12 ECG ANALYSIS MODULE MODEL # 0998-00-0170-XXXX
- K013046 — COSMOS SYSTEM
- K022453 — MODIFICATION TO ACUITY CENTRAL MONITORING SYSTEM
- K021376 — DATEX-OHMEDA S/5 CRITICAL CARE MONITOR WITH L-ICU02 AND L-ICU02A SOFTWARE
- K021097 — QUEST EXERCISE STRESS SYSTEM (QUEST), VERSION 3.52
- K021300 — MODIFICATION OF PHILIPS COMPONENT COMPACT MONITOR, RELEASE A.03, MODEL M1275B
- K021251 — ST/AR ST AND ARRHYTHMIA SOFTWARE, RELEASE E.I.
- K012467 — SOLAR 8000M SYSTEM
- K002604 — CENTURION 2000 CENTRAL STATION ARRHYTHMIA PATIENT MONITORING SYSTEM
- K020084 — FUKUDA DENSHI DYNASCOPE MODEL DS-5700
- K012241 — CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1001
- K014159 — PHILLIPS M1175A/76A/77A COMPONENT MONITORING SYSTEM; PHILLIPS V24/V26 PATIENT MONITOR
- K012336 — MODIFICATION TO:ESCORT VISION CENTRAL STATION TELEMETRY SYSTEM, MODEL 20500
- K011339 — QUEST EXERCISE STRESS SYSTEM, MODEL CONFIGURATION 14
- K012461 — SIEMENS INFINITY MIB II DUO PROTOCOL CONVERTER
- K011784 — MODIFICATION TO ENVOY PATIENT MONITOR
- K011824 — AGILENT M2636B TELEMON B MONITOR (TELEMON B)
- K001120 — ENVOY PATIENT MONITOR
- K002758 — AGILENT COMPONENT MONITORING SYSTEM, AGILENT CARDIAC OUTPUT MODULE, AGILENT INVASIVE PRESSURE MODULE, MODEL M1175A/76A
- K002068 — ORG-9200A
- K003576 — Q-TEL RMS (REHABILITATION MANAGEMENT SYSTEM), MODEL 000503
- K003246 — SIEMENS MULTI VIEW WORKSTATION WITH VENT VIEWER OPTION
- K003179 — SIEMENS MULTIVIEW INFINITY TELEMETRY SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.