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) → MXD — Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection) # MXD · Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection) _Cardiovascular · 21 CFR 870.1025 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MXD ## Overview - **Product Code:** MXD - **Device Name:** Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection) - **Regulation:** [21 CFR 870.1025](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1025) - **Device Class:** 2 - **Review Panel:** [Cardiovascular](/submissions/CV) - **Implant:** yes ## 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 32) Showing 20 most recent of 32 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K253516](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MXD/K253516.md) | Assert-IQ (DM5100) | ABBOTT MEDICAL | Dec 18, 2025 | SESE | | [K251221](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MXD/K251221.md) | Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000) | Abbott | Sep 17, 2025 | SESE | | [K252593](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MXD/K252593.md) | LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monitor (M312) | Boston Scientific Corporation | Sep 12, 2025 | SESE | | [K240693](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MXD/K240693.md) | LINQ II™ Insertable Cardiac Monitor (ICM) | Medtronic, Inc. | Mar 28, 2024 | SESE | | [K233562](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MXD/K233562.md) | LINQ II Insertable Cardiac Monitor | Medtronic, Inc. | Dec 6, 2023 | SESE | | [K233320](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MXD/K233320.md) | LINQ II™ Insertable Cardiac Monitor (LNQ22) | Medtronic, Inc. | Oct 31, 2023 | SESE | | [K231328](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MXD/K231328.md) | LUX-Dx II (M302); LUX-Dx II+ (M312) | Boston Scientific Corp | Aug 19, 2023 | SESE | | [K230375](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MXD/K230375.md) | BIOMONITOR IV | Biotronik, Inc. | May 19, 2023 | SESE | | [K230553](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MXD/K230553.md) | LINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ II ICM Application | Medtronic, Inc. | Apr 26, 2023 | SESE | | [K223630](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MXD/K223630.md) | Reveal LINQ Insertable Cardiac Monitor, LINQ II Insertable Cardiac Monitor, AccuRhythm AI ECG Classification System | Medtronic, Inc. | Apr 5, 2023 | SESE | | [K221962](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MXD/K221962.md) | LINQ II Insertable Cardiac Monitor | Medtronic, Inc. | Aug 25, 2022 | SESE | | [K221856](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MXD/K221856.md) | BIOMONITOR IIIm, BIOMONITOR III | Biotronik, Inc. | Jul 27, 2022 | SESE | | [K212008](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MXD/K212008.md) | Reveal LINQ Insertable Cardiac Monitor | Medtronic, Inc. | Jul 22, 2021 | SESE | | [K210484](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MXD/K210484.md) | LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification System | Medtronic, Inc. | Jun 11, 2021 | SESE | | [K211304](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MXD/K211304.md) | LINQ II Insertable Cardiac Monitor | Medtronic, Inc. | May 28, 2021 | SESE | | [K210608](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MXD/K210608.md) | LUX-Dx Insertable Cardiac Monitor | Boston Scientific Corporation | May 25, 2021 | SESE | | [K201865](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MXD/K201865.md) | Biomonitor III, Biomonitor IIIm | Biotronik, Inc. | Dec 8, 2020 | SESE | | [K200795](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MXD/K200795.md) | LINQ II Insertable Cardiac Monitor, LINQ Mobile Manager, Device Command Library, Instrument Command Library, LINQ Tool Kit | Medtronic, Inc. | Jul 3, 2020 | SESE | | [K193473](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MXD/K193473.md) | LUX-Dx Insertable Cardiac Monitor, myLUX Software Mobile Application, LUX-Dx Clinic Assistant Software, Application Server Device Services (DS) - US | Boston Scientific Corporation | Jun 26, 2020 | SESE | | [K200444](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MXD/K200444.md) | Biomonitor III, Biomonitor IIIm | Biotronik, Inc. | Apr 23, 2020 | SESE | ## Top Applicants - Medtronic, Inc. — 16 clearances - Biotronik, Inc. — 10 clearances - Boston Scientific Corporation — 3 clearances - ABBOTT MEDICAL — 1 clearance - Abbott — 1 clearance --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MXD](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MXD) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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