MXD · Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)
Cardiovascular · 21 CFR 870.1025 · Class 2
Overview
| Product Code | MXD |
|---|---|
| Device Name | Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection) |
| Regulation | 21 CFR 870.1025 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| 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 | Assert-IQ (DM5100) | ABBOTT MEDICAL | Dec 18, 2025 | SESE |
| K251221 | Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000) | Abbott | Sep 17, 2025 | SESE |
| K252593 | LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monitor (M312) | Boston Scientific Corporation | Sep 12, 2025 | SESE |
| K240693 | LINQ II Insertable Cardiac Monitor (ICM) | Medtronic, Inc. | Mar 28, 2024 | SESE |
| K233562 | LINQ II Insertable Cardiac Monitor | Medtronic, Inc. | Dec 6, 2023 | SESE |
| K233320 | LINQ II Insertable Cardiac Monitor (LNQ22) | Medtronic, Inc. | Oct 31, 2023 | SESE |
| K231328 | LUX-Dx II (M302); LUX-Dx II+ (M312) | Boston Scientific Corp | Aug 19, 2023 | SESE |
| K230375 | BIOMONITOR IV | Biotronik, Inc. | May 19, 2023 | SESE |
| K230553 | LINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ II ICM Application | Medtronic, Inc. | Apr 26, 2023 | SESE |
| K223630 | Reveal LINQ Insertable Cardiac Monitor, LINQ II Insertable Cardiac Monitor, AccuRhythm AI ECG Classification System | Medtronic, Inc. | Apr 5, 2023 | SESE |
| K221962 | LINQ II Insertable Cardiac Monitor | Medtronic, Inc. | Aug 25, 2022 | SESE |
| K221856 | BIOMONITOR IIIm, BIOMONITOR III | Biotronik, Inc. | Jul 27, 2022 | SESE |
| K212008 | Reveal LINQ Insertable Cardiac Monitor | Medtronic, Inc. | Jul 22, 2021 | SESE |
| K210484 | LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification System | Medtronic, Inc. | Jun 11, 2021 | SESE |
| K211304 | LINQ II Insertable Cardiac Monitor | Medtronic, Inc. | May 28, 2021 | SESE |
| K210608 | LUX-Dx Insertable Cardiac Monitor | Boston Scientific Corporation | May 25, 2021 | SESE |
| K201865 | Biomonitor III, Biomonitor IIIm | Biotronik, Inc. | Dec 8, 2020 | SESE |
| K200795 | LINQ II Insertable Cardiac Monitor, LINQ Mobile Manager, Device Command Library, Instrument Command Library, LINQ Tool Kit | Medtronic, Inc. | Jul 3, 2020 | SESE |
| K193473 | 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 | 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
