# K151188: BodyGuardian Remote Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Preventice
- Decided: Sep 17, 2015 after 136 days
- Product code: DSI (Detector And Alarm, Arrhythmia)
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) eMotion Faros ECG Mobile: named in the summary without a submission number
- (no number) BodyGuardian Remote Monitoring System: named in the summary without a submission number

## Most influential descendants
- K192732: BodyGuardian Remote Monitoring System (2020), 1 descendant of its own
- K243349: BodyGuardian Remote Monitoring System (BGRMS v3.0) (2026), 0 descendants of its own
- K181658: MobileECG 2 BT (2019), 0 descendants of its own

## Recalls of this device
- Aug 6, 2019 · Class II · Z-2479-2020: The device data being collected and transferred to the monitoring center may not be accurate due to nonvalidated association between the phone software and the heart monitors, therefore, the patient's

## Indications for use
The BodyGuardian System detects and monitors cardiac arrhythmias in ambulatory patients, when prescribed by a physician or other qualified healthcare professional. Not for use with patients requiring attended, In-hospital monitoring for life threatening arrhythmias. The Preventice BodyGuardian Remote Monitoring System is intended for use with adult patients in clinical and non-clinical settings to collect and transmit health parameters to healthcare professionals for monitoring and evaluation. Health parameters are collected from a variety of commercially available, external plug in devices such as ECG sensors, Weight Scales, Blood Pressure Meters and Pulse Oximeters. The Preventice BodyGuardian Remote Monitoring System does not provide any diagnosis.

Source page: https://510kreport.com/device/K151188
Methodology: https://510kreport.com/methodology