Cleared Traditional

K231328 - LUX-Dx II (M302) (FDA 510(k) Clearance)

Also includes:
LUX-Dx II+ (M312)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K231328 · Boston Scientific Corp · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2023
Decision
103d
Days
Class 2
Risk

K231328 is an FDA 510(k) clearance for the LUX-Dx II (M302). Classified as Recorder, Event, Implantable Cardiac, (with Arrhythmia Detection) (product code MXD), Class II - Special Controls.

Submitted by Boston Scientific Corp (St Paul, US). The FDA issued a Cleared decision on August 19, 2023 after a review of 103 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 Boston Scientific Corp devices

Submission Details

510(k) Number K231328 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 2023
Decision Date August 19, 2023
Days to Decision 103 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
22d faster than avg
Panel avg: 125d · This submission: 103d
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 K231328.
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K251221 · Abbott · Sep 2025
LUX-Dx II Insertable Cardiac Monitor (M302)
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