DSI · Detector And Alarm, Arrhythmia
Cardiovascular · 21 CFR 870.1025 · Class 2
Overview
| Product Code | DSI |
|---|---|
| Device Name | Detector And Alarm, Arrhythmia |
| Regulation | 21 CFR 870.1025 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
Identification
The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.
Classification Rationale
Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.
Special Controls
*Classification.* Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.
Recent Cleared Devices (20 of 398)
Showing 20 most recent of 398 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K243349 | BodyGuardian Remote Monitoring System (BGRMS v3.0) | Boston Scientific Cardiac Diagnostic Technologies, Inc. | Jan 23, 2026 | SESE |
| K250356 | MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000) | Infobionic, Inc. | Jul 29, 2025 | SESE |
| K240177 | Zio AT® device (A100A1001) | iRhythm Technologies, Inc. | Oct 30, 2024 | SESE |
| K230265 | MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System | Infobionic, Inc. | Oct 6, 2023 | SESE |
| K231276 | SmartCardia 7L Platform | Smartcardia SA | Aug 30, 2023 | SESE |
| K193104 | Unified Arrhythmia Diagnostic System PocketECG IV | Medicalgorithmics S.A. | Apr 9, 2020 | SESE |
| K192732 | BodyGuardian Remote Monitoring System | Preventice Technologies, Inc. | Mar 26, 2020 | SESE |
| K190574 | Patient Assistant Model PA97000 | Medtronic, Inc. | Sep 24, 2019 | SESE |
| K182532 | Liba3 System | National Cardiac, Inc. | May 15, 2019 | SESE |
| K181658 | MobileECG 2 BT | Memtec Corporation | Mar 26, 2019 | SESE |
| K173969 | Medicalgorithmics Unified Cardiac Rehabilitation System | Medicalgorithmics S.A. | Jul 11, 2018 | SESE |
| K173170 | Epicardia Anywhere | Medicomp, Inc. | Jan 10, 2018 | SESE |
| K153473 | Braemar Telemetry Patch System | Braemar Manufacturing, LLC | Jul 22, 2016 | SESE |
| K153477 | EMMa Electronic Monitoring Management | Vitasystems GmbH | May 25, 2016 | SESE |
| K152701 | Matrix Mini ECG Monitor | Global Instrumentation, LLC | Apr 22, 2016 | SESE |
| K152305 | Nihon Kohden Afib Detection Program QP-039P | Nihon Kohden Corporation | Apr 8, 2016 | SESE |
| K151835 | Vital Signs Patch System | Lifewatch Technologies , Ltd. | Feb 5, 2016 | SESE |
| K151269 | ECG Mini System Continuous ECG Monitor and Arrhythmia Detector | Lifewatch Technologies , Ltd. | Jan 15, 2016 | SESE |
| K152491 | MoMe Software Platform | Infobionic, Inc. | Dec 17, 2015 | SESE |
| K152550 | MEDICALGORITHMICS UNIFIED ARRHYTHMIA DIAGNOSIC SYSTEM | Medicalgorithmics S.A. | Oct 8, 2015 | SESE |
Top Applicants
- Siemens Medical Solutions USA, Inc. — 27 clearances
- Fukuda Denshi USA, Inc. — 19 clearances
- Nihon Kohden America, Inc. — 18 clearances
- Hewlett-Packard Co. — 17 clearances
- Oxford Medilog, Inc. — 14 clearances
