# K992696: Ecg Minimonitor, Model CG-5000

- Pathway: 510(k) (Traditional)
- Applicant: Card Guard Scientific Survival, Ltd.
- Decided: Oct 7, 1999 after 56 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.
56 later devices descend from it; 1 cites it directly.
0 of 57 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
- K060766: Portable,  Electrocardiograph (Ecg) Monitor, Model HCG-801 (2006), 55 descendants of its own
- K093872: Handheld Ecg Monitor, Model MD100 (2010), 37 descendants of its own
- K111438: REKA E100 (2011), 32 descendants of its own
- K121628: Epi Mini Ecg Portable Health Monitoring System (Epi Mini) (2013), 31 descendants of its own
- K143513: ZIO SR ECG Monitoring Service (2015), 30 descendants of its own

## Indications for use
CG-5000 ECG MiniMonitor is a medical device intended for recording, display, output to the electrocardiograph recorder, and, optionally, transtelephonic transmission of the ECG signal for the purpose of cardiac conditions analysis.

Source page: https://510kreport.com/device/K992696
Methodology: https://510kreport.com/methodology