Cleared Traditional

K143503 - BioMonitor

K143503 is an FDA 510(k) clearance for BioMonitor, 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 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

FDA 510(k) Submission Details - K143503

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.

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 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