# K081257: CG-6108 Act-3L Continuous Ecg Monitor & Arrhythmia Detector

- Pathway: 510(k) (Special)
- Applicant: Card Guard Scientific Survival, Ltd.
- Decided: May 29, 2008 after 27 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: 5 generations back to K963725 (1997). 14 ancestors in all.
18 later devices descend from it; 3 cite it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071995: CG-6108 Continuous Ecg Monitor and Arrhythmia Detector, Card Guard Scientific Survival, Ltd. (2007) Summary page 1.
- K990478: Card Guard, Model CG-6550, Card Guard Scientific Survival, Ltd. (1999) Summary page 1.

## Most influential descendants
- K093288: Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection (2010), 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
- K101703: Modification to: CG-6108 Act-3L Continuous Ecg Monitor and Arrhythmia Detector, Model FG-00084 (2010), 3 descendants of its own
- K151787: Holter System (2016), 2 descendants of its own

## Recalls of this device
- Sep 26, 2011 · Not classified · Z-0207-2012: 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 ACT-3L 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 patient 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/K081257
Methodology: https://510kreport.com/methodology