Cleared Traditional

BodyGuardian Remote Monitoring System (BGRMS v3.0)

K243349 · Boston Scientific Cardiac Diagnostic Technologies, Inc. · Cardiovascular

Jan 2026

Decision

452d

Days

Class 2

Risk

About This 510(k) Submission

K243349 is an FDA 510(k) clearance for the BodyGuardian Remote Monitoring System (BGRMS v3.0), a Detector And Alarm, Arrhythmia (Class II — Special Controls, product code DSI), submitted by Boston Scientific Cardiac Diagnostic Technologies, Inc. (Rochester, US). The FDA issued a Cleared decision on January 23, 2026, 452 days after receiving the submission on October 28, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1025.

Submission Details

510(k) Number	K243349 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 28, 2024
Decision Date	January 23, 2026
Days to Decision	452 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF