Cleared Traditional

K201865 - Biomonitor III, Biomonitor IIIm

K201865 is an FDA 510(k) clearance for Biomonitor III, manufactured by Biotronik, Inc.. The device is a Class 2 Cardiovascular device with product code MXD cleared through the Traditional 510(k) pathway after a 155-day FDA review.

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

K201865 is an FDA 510(k) clearance for the Biomonitor III, Biomonitor IIIm. Classified as Recorder, Event, Implantable Cardiac, (with Arrhythmia Detection) (product code MXD), Class II - Special Controls.

Submitted by Biotronik, Inc. (Lake Oswego, US). The FDA issued a Cleared decision on December 8, 2020 after a review of 155 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1025 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Biotronik, Inc. devices

FDA 510(k) Submission Details - K201865

510(k) Number K201865 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
30d slower than avg
Panel avg: 125d · This submission: 155d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MXD Device Classification - Class 2, Special Controls

Product Code MXD Recorder, Event, Implantable Cardiac, (with Arrhythmia Detection)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1025
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - MXD Recorder, Event, Implantable Cardiac, (with Arrhythmia Detection)

All 33
Devices cleared under the same product code (MXD) and FDA review panel - the closest regulatory comparables to K201865.
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K193473 · Boston Scientific Corporation · Jun 2020
Biomonitor III, Biomonitor IIIm
K200444 · Biotronik, Inc. · Apr 2020