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/productcode/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 33)

Showing 20 most recent of 33 cleared devices.

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K261074](/device/K261074.md) | BIOMONITOR IV (471155) | Biotronik, Inc. | May 1, 2026 | SESE |
| [K253516](/device/K253516.md) | Assert-IQ (DM5100) | ABBOTT MEDICAL | Dec 18, 2025 | SESE |
| [K251221](/device/K251221.md) | Assert-IQ  (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000) | Abbott | Sep 17, 2025 | SESE |
| [K252593](/device/K252593.md) | LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monitor (M312) | Boston Scientific Corporation | Sep 12, 2025 | SESE |
| [K240693](/device/K240693.md) | LINQ II™ Insertable Cardiac Monitor (ICM) | Medtronic, Inc. | Mar 28, 2024 | SESE |
| [K233562](/device/K233562.md) | LINQ II Insertable Cardiac Monitor | Medtronic, Inc. | Dec 6, 2023 | SESE |
| [K233320](/device/K233320.md) | LINQ II™ Insertable Cardiac Monitor (LNQ22) | Medtronic, Inc. | Oct 31, 2023 | SESE |
| [K231328](/device/K231328.md) | LUX-Dx II (M302); LUX-Dx II+ (M312) | Boston Scientific Corp | Aug 19, 2023 | SESE |
| [K230375](/device/K230375.md) | BIOMONITOR IV | Biotronik, Inc. | May 19, 2023 | SESE |
| [K230553](/device/K230553.md) | LINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ II ICM Application | Medtronic, Inc. | Apr 26, 2023 | SESE |
| [K223630](/device/K223630.md) | Reveal LINQ Insertable Cardiac Monitor, LINQ II Insertable Cardiac Monitor, AccuRhythm AI ECG Classification System | Medtronic, Inc. | Apr 5, 2023 | SESE |
| [K221962](/device/K221962.md) | LINQ II Insertable Cardiac Monitor | Medtronic, Inc. | Aug 25, 2022 | SESE |
| [K221856](/device/K221856.md) | BIOMONITOR IIIm, BIOMONITOR III | Biotronik, Inc. | Jul 27, 2022 | SESE |
| [K212008](/device/K212008.md) | Reveal LINQ Insertable Cardiac Monitor | Medtronic, Inc. | Jul 22, 2021 | SESE |
| [K210484](/device/K210484.md) | LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification System | Medtronic, Inc. | Jun 11, 2021 | SESE |
| [K211304](/device/K211304.md) | LINQ II Insertable Cardiac Monitor | Medtronic, Inc. | May 28, 2021 | SESE |
| [K210608](/device/K210608.md) | LUX-Dx Insertable Cardiac Monitor | Boston Scientific Corporation | May 25, 2021 | SESE |
| [K201865](/device/K201865.md) | Biomonitor III, Biomonitor IIIm | Biotronik, Inc. | Dec 8, 2020 | SESE |
| [K200795](/device/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](/device/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 |

## Top Applicants

- Medtronic, Inc. — 16 clearances
- Biotronik, Inc. — 11 clearances
- Boston Scientific Corporation — 3 clearances
- ABBOTT MEDICAL — 1 clearance
- Abbott — 1 clearance

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**Source:** [https://fda.innolitics.com/productcode/MXD](https://fda.innolitics.com/productcode/MXD)

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