# K990478: Card Guard, Model CG-6550

- Pathway: 510(k) (Traditional)
- Applicant: Card Guard Scientific Survival, Ltd.
- Decided: Aug 31, 1999 after 196 days
- Product code: DXH (Transmitters And Receivers, Electrocardiograph, Telephone)
- Device class: 2
- Regulation: 21 CFR 870.2920
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
19 later devices descend from it; 1 cites it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## 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
- 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

## Indications for use
The CG-6550 is a Personal 3-Lead Electrocardiogram (ECG) Transmitter intended for long-term monitoring of cardiac patients, for detection of rhythm disorders and ST-changes.

Source page: https://510kreport.com/device/K990478
Methodology: https://510kreport.com/methodology