Cleared Special

LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monitor (M312)

K252593 · Boston Scientific Corporation · Cardiovascular

Sep 2025

Decision

28d

Days

Class 2

Risk

About This 510(k) Submission

K252593 is an FDA 510(k) clearance for the LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monitor (M312), a Recorder, Event, Implantable Cardiac, (with Arrhythmia Detection) (Class II — Special Controls, product code MXD), submitted by Boston Scientific Corporation (Alternate Contact, US). The FDA issued a Cleared decision on September 12, 2025, 28 days after receiving the submission on August 15, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1025.

Submission Details

510(k) Number	K252593 FDA.gov
FDA Decision	Cleared 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

Device Classification

Product Code	MXD — Recorder, Event, Implantable Cardiac, (with Arrhythmia Detection)
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.1025