Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart B — Cardiovascular Diagnostic Devices](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices) → [21 CFR 870.1025](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1025) → DSI — Detector And Alarm, Arrhythmia # DSI · Detector And Alarm, Arrhythmia _Cardiovascular · 21 CFR 870.1025 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DSI ## Overview - **Product Code:** DSI - **Device Name:** Detector And Alarm, Arrhythmia - **Regulation:** [21 CFR 870.1025](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1025) - **Device Class:** 2 - **Review Panel:** [Cardiovascular](/submissions/CV) ## 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](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DSI/K243349.md) | BodyGuardian Remote Monitoring System (BGRMS v3.0) | Boston Scientific Cardiac Diagnostic Technologies, Inc. | Jan 23, 2026 | SESE | | [K250356](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DSI/K250356.md) | MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000) | Infobionic, Inc. | Jul 29, 2025 | SESE | | [K240177](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DSI/K240177.md) | Zio AT® device (A100A1001) | iRhythm Technologies, Inc. | Oct 30, 2024 | SESE | | [K230265](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DSI/K230265.md) | MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System | Infobionic, Inc. | Oct 6, 2023 | SESE | | [K231276](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DSI/K231276.md) | SmartCardia 7L Platform | Smartcardia SA | Aug 30, 2023 | SESE | | [K193104](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DSI/K193104.md) | Unified Arrhythmia Diagnostic System PocketECG IV | Medicalgorithmics S.A. | Apr 9, 2020 | SESE | | [K192732](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DSI/K192732.md) | BodyGuardian Remote Monitoring System | Preventice Technologies, Inc. | Mar 26, 2020 | SESE | | [K190574](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DSI/K190574.md) | Patient Assistant Model PA97000 | Medtronic, Inc. | Sep 24, 2019 | SESE | | [K182532](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DSI/K182532.md) | Liba3 System | National Cardiac, Inc. | May 15, 2019 | SESE | | [K181658](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DSI/K181658.md) | MobileECG 2 BT | Memtec Corporation | Mar 26, 2019 | SESE | | [K173969](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DSI/K173969.md) | Medicalgorithmics Unified Cardiac Rehabilitation System | Medicalgorithmics S.A. | Jul 11, 2018 | SESE | | [K173170](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DSI/K173170.md) | Epicardia Anywhere | Medicomp, Inc. | Jan 10, 2018 | SESE | | [K153473](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DSI/K153473.md) | Braemar Telemetry Patch System | Braemar Manufacturing, LLC | Jul 22, 2016 | SESE | | [K153477](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DSI/K153477.md) | EMMa Electronic Monitoring Management | Vitasystems GmbH | May 25, 2016 | SESE | | [K152701](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DSI/K152701.md) | Matrix Mini ECG Monitor | Global Instrumentation, LLC | Apr 22, 2016 | SESE | | [K152305](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DSI/K152305.md) | Nihon Kohden Afib Detection Program QP-039P | Nihon Kohden Corporation | Apr 8, 2016 | SESE | | [K151835](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DSI/K151835.md) | Vital Signs Patch System | Lifewatch Technologies , Ltd. | Feb 5, 2016 | SESE | | [K151269](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DSI/K151269.md) | ECG Mini System Continuous ECG Monitor and Arrhythmia Detector | Lifewatch Technologies , Ltd. | Jan 15, 2016 | SESE | | [K152491](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DSI/K152491.md) | MoMe Software Platform | Infobionic, Inc. | Dec 17, 2015 | SESE | | [K152550](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DSI/K152550.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DSI](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DSI) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com