# K243349: BodyGuardian Remote Monitoring System (BGRMS v3.0)

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Cardiac Diagnostic Technologies, Inc.
- Decided: Jan 23, 2026 after 452 days
- Product code: DSI (Detector And Alarm, Arrhythmia)
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K001134 (2000). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192732: BodyGuardian Remote Monitoring System, Preventice Technologies, Inc. (2020) Summary page 5.
- K240653: SmartCardia 7L Platform (MCT), Smartcardia SA (2024). Cleared while this submission was under review Summary page 6.

## Indications for use
The BodyGuardian™ Remote Monitoring System detects and monitors cardiac arrhythmias in ambulatory patients, when prescribed by a physician or other qualified healthcare professional. The BodyGuardian Remote Monitoring System is intended for use with adult and pediatric patients who are at least 29 days old in clinical and non-clinical settings to collect and transmit electrocardiogram (ECG) and other health parameters to healthcare professionals for monitoring and evaluation. Health parameters, such as heart rate and ECG data, are collected from external devices such as ECG sensors. The BodyGuardian Remote Monitoring System does not provide any diagnosis. Contraindications: The BodyGuardian Remote Monitoring System is contraindicated for those patients requiring attended, in-hospital monitoring for life threatening arrhythmias. Not for use for detection or notification of hemodynamically unstable or life-threatening arrhythmias or cardiac events requiring urgent medical response.

Source page: https://510kreport.com/device/K243349
Methodology: https://510kreport.com/methodology