# K192732: BodyGuardian Remote Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Preventice Technologies, Inc.
- Decided: Mar 26, 2020 after 181 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: 1 generation back to K151188 (2015). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151188: BodyGuardian Remote Monitoring System, Preventice (2015) Summary page 4.

## Most influential descendants
- K243349: BodyGuardian Remote Monitoring System (BGRMS v3.0) (2026), 0 descendants of its own

## 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 and pediatric 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, and parameters such as ECG, heart rate, body weight, temperature, respiration rate, blood pressure, and SpO2. The Preventice BodyGuardian Remote Monitoring System does not provide any diagnosis.

Source page: https://510kreport.com/device/K192732
Methodology: https://510kreport.com/methodology