Cleared Traditional

K193473 - LUX-Dx Insertable Cardiac Monitor, myLUX Software Mobile Application, LUX-Dx Clinic Assistant Software, Application Server Device Services (DS) - US

K193473 is an FDA 510(k) clearance for LUX-Dx Insertable Cardiac Monitor, manufactured by Boston Scientific Corporation. The device is a Class 2 Cardiovascular device with product code MXD cleared through the Traditional 510(k) pathway after a 193-day FDA review.

K193473 · Boston Scientific Corporation · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2020
Decision
193d
Days
Class 2
Risk

K193473 is an FDA 510(k) clearance for the LUX-Dx Insertable Cardiac Monitor, myLUX Software Mobile Application, LUX-Dx .... Classified as Recorder, Event, Implantable Cardiac, (with Arrhythmia Detection) (product code MXD), Class II - Special Controls.

Submitted by Boston Scientific Corporation (St Paul, US). The FDA issued a Cleared decision on June 26, 2020 after a review of 193 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 Boston Scientific Corporation devices

FDA 510(k) Submission Details - K193473

510(k) Number K193473 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 2019
Decision Date June 26, 2020
Days to Decision 193 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
68d slower than avg
Panel avg: 125d · This submission: 193d
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 K193473.
LUX-Dx Insertable Cardiac Monitor
K210608 · Boston Scientific Corporation · May 2021
Biomonitor III, Biomonitor IIIm
K201865 · Biotronik, Inc. · Dec 2020
LINQ II Insertable Cardiac Monitor, LINQ Mobile Manager, Device Command Library, Instrument Command Library, LINQ Tool Kit
K200795 · Medtronic, Inc. · Jul 2020
Biomonitor III, Biomonitor IIIm
K200444 · Biotronik, Inc. · Apr 2020
BIOMONITOR III, Remote Assistant III
K190548 · Biotronik, Inc. · Jul 2019
BioMonitor 2-AF, BioMonitor 2-S, FIT - Fast Insert Tool 1 + 2, Set
K171514 · Biotronik, Inc. · Jun 2017