Cleared Traditional

Biomonitor III, Biomonitor IIIm

K201865 · Biotronik, Inc. · Cardiovascular
Dec 2020
Decision
155d
Days
Class 2
Risk

About This 510(k) Submission

K201865 is an FDA 510(k) clearance for the Biomonitor III, Biomonitor IIIm, a Recorder, Event, Implantable Cardiac, (with Arrhythmia Detection) (Class II — Special Controls, product code MXD), submitted by Biotronik, Inc. (Lake Oswego, US). The FDA issued a Cleared decision on December 8, 2020, 155 days after receiving the submission on July 6, 2020. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1025.

Submission Details

510(k) Number K201865 FDA.gov
FDA Decision Cleared SESE
Date Received July 06, 2020
Decision Date December 08, 2020
Days to Decision 155 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code MXD — Recorder, Event, Implantable Cardiac, (with Arrhythmia Detection)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1025

Similar Devices — MXD Recorder, Event, Implantable Cardiac, (with Arrhythmia Detection)

All 31
Assert-IQ (DM5100)
K253516 · Abbott Medical · Dec 2025
Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000)
K251221 · Abbott · Sep 2025
LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monitor (M312)
K252593 · Boston Scientific Corporation · Sep 2025
LINQ II? Insertable Cardiac Monitor (ICM)
K240693 · Medtronic, Inc. · Mar 2024
LINQ II Insertable Cardiac Monitor
K233562 · Medtronic, Inc. · Dec 2023
LINQ II? Insertable Cardiac Monitor (LNQ22)
K233320 · Medtronic, Inc. · Oct 2023

More from Biotronik, Inc.

View all
Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters; Passeo-14 Peripheral Dilatation Catheter; Oscar Peripheral Multifunctional Catheter System; Pantera Pro Percutaneous Transluminal Coronary Angioplasty Catheter; Pantera LEO Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter
K250706 · LIT · Apr 2025
Pantera Pro; Pantera LEO
K242969 · LOX · Oct 2024
Selectra 3D Lead Delivery System (443624-443629, 451789-451791); Selectra Slitter Tool (383119); Selectra Accessory Kit (375518)
K240787 · DQY · Sep 2024
Oscar Peripheral Multifunctional Catheter system
K241711 · LIT · Jul 2024
BIOMONITOR IV
K230375 · MXD · May 2023