Cleared Special

K252593 - LUX-Dx II Insertable Cardiac Monitor (M302) (FDA 510(k) Clearance)

Also includes:
LUX-Dx II+ Insertable Cardiac Monitor (M312)

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K252593 · Boston Scientific Corporation · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2025
Decision
28d
Days
Class 2
Risk

K252593 is an FDA 510(k) clearance for the LUX-Dx II Insertable Cardiac Monitor (M302). 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 September 12, 2025 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1025 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Boston Scientific Corporation devices

Submission Details

510(k) Number K252593 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 2025
Decision Date September 12, 2025
Days to Decision 28 days
Submission Type Special
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
97d faster than avg
Panel avg: 125d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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 K252593.
BIOMONITOR IV (471155)
K261074 · Biotronik, Inc. · May 2026
Assert-IQ (DM5100)
K253516 · Abbott Medical · Dec 2025
Assert-IQ (DM5000)
K251221 · Abbott · Sep 2025
LINQ II™ Insertable Cardiac Monitor (ICM)
K240693 · Medtronic, Inc. · Mar 2024
LINQ II Insertable Cardiac Monitor
K233562 · Medtronic, Inc. · Dec 2023
LINQ II™ Insertable Cardiac Monitor (LNQ22)
K233320 · Medtronic, Inc. · Oct 2023