Cleared Traditional

K143503 - BioMonitor

K143503 is the FDA 510(k) clearance for BioMonitor by Biotronik, Inc.. It is a Class 2 Cardiovascular device (product code MXD) cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K143503 · Biotronik, Inc. · Cardiovascular device
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Mar 2015
Decision
99d
Days
Class 2
Risk

K143503 is an FDA 510(k) clearance for the BioMonitor. 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 March 19, 2015 after a review of 99 days - within the typical 510(k) review window.

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

Submission Details

510(k) Number K143503 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 2014
Decision Date March 19, 2015
Days to Decision 99 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
26d faster than avg
Panel avg: 125d · This submission: 99d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 32
Devices cleared under the same product code (MXD) and FDA review panel - the closest regulatory comparables to K143503.
Reveal LINQ
K160689 · Medtronic, Inc. · Apr 2016
BioMonitor 2-AF, BioMonitor 2-S
K152995 · Biotronik, Inc. · Apr 2016
Reveal LINQ
K150614 · Medtronic, Inc. · Aug 2015
BIOMONITOR
K132960 · Biotronik, Inc. · Jun 2014
REVEAL LINQ INSERTABLE CARDIAC MONITOR
K132649 · Medtronic, Inc. · Feb 2014