# K071995: CG-6108 Continuous Ecg Monitor and Arrhythmia Detector

- Pathway: 510(k) (Traditional)
- Applicant: Card Guard Scientific Survival, Ltd.
- Decided: Dec 18, 2007 after 151 days
- Product code: DSI (Detector And Alarm, Arrhythmia)
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K963725 (1997). 12 ancestors in all.
25 later devices descend from it; 4 cite it directly.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060911: CG-6108 Arrhythmia Ecg Event Recorder, Card Guard Scientific Survival, Ltd. (2006) Summary page 2.
- K982803: Heartlink, Model II, Cardiac Telecom Corp. (1998) Summary page 2.

## Most influential descendants
- K081257: CG-6108 Act-3L Continuous Ecg Monitor & Arrhythmia Detector (2008), 18 descendants of its own
- K093288: Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection (2010), 7 descendants of its own
- K090037: Medicalgorithmics Real-Time Ecg Monitor and Arrhythmia Detector, Model Pocketecg (2009), 7 descendants of its own
- K100155: Truvue Wireless Ambulatory Ecg Monitoring System (2010), 6 descendants of its own
- K160064: MoMe Kardia Wireless Ambulatory ECG Monitoring and Detection System (2016), 3 descendants of its own

## Recalls of this device
- Sep 26, 2011 · Not classified · Z-0206-2012: LifeWatch received complaints of minor shocks and burns during use of the LifeStar ACT systems with shorts in the leads.
- Sep 26, 2011 · Not classified · Z-0208-2012: LifeWatch received complaints of minor shocks and burns during use of the LifeStar ACT systems with shorts in the leads.

## Indications for use
The CG-6108 Continuous ECG Monitor and Arrhythmia Detector is intended for use by patients who experience transient symptoms that may suggest cardiac arrhythmia. The device continuously monitors a one lead ECG, automatically generates an alarm triggered by an arrhythmia detection algorithm or generates an alarm manually triggered by the patient, and transmits the recorded data transtelephonically to a monitoring center. The monitoring center provides the ECG data to the medical practitioner for evaluation.

Source page: https://510kreport.com/device/K071995
Methodology: https://510kreport.com/methodology