# K121197: Bodyguardian System Bodyguardian Control Unit Bodyguardian Connect

- Pathway: 510(k) (Traditional)
- Applicant: Preventice, Inc.
- Decided: Aug 10, 2012 after 113 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: 6 generations back to K882803 (1988). 11 ancestors in all.
10 later devices descend from it; 4 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083287: Avivo Mobile Patient Management System, Corventis, Inc. (2009) Summary page 1.

## Most influential descendants
- K193296: eCordum Cardiac Monitor (eCordum CM) (2020), 3 descendants of its own
- K222842: V-Patch Cardiac Monitor (2022), 1 descendant of its own
- K162956: Nowcardio System (2017), 1 descendant of its own
- K133753: Mome Ecg Continuous Detection and Arrhythmia Detector (2014), 1 descendant of its own
- K132447: Vitalconnect Platform by Vital Connect Inc. (2014), 1 descendant of its own

## Indications for use
The BodyGuardian System detects and monitors non-lethal cardiac arrhythmias in ambulatory patients, when prescribed by a physician or other qualified healthcare professional. The BodyGuardian System continuously records, stores and periodically transmits the following physiological data to a remote computer server for up to 30 days at a time: *ECG *Heart rate (including HIR variability and HR reliability) *Respiration rate *Activity

Source page: https://510kreport.com/device/K121197
Methodology: https://510kreport.com/methodology