# K020366: Global Ecg Management System (Gems)

- Pathway: 510(k) (Traditional)
- Applicant: Cardiocomm Solutions, Inc.
- Decided: Apr 30, 2002 after 85 days
- Product code: DPS (Electrocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K955023 (1997). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955023: Brentwood PC-Ecg, Brentwood Medical Products, Inc. (1997) Summary page 1.

## Most influential descendants
- K022297: Global Ecg Management System (Gems) (2002), 0 descendants of its own

## Indications for use
GEMS is intended to be used as a data management tool for cardiologists, general practitioners, cardiac or ECG technicians, nurses, monitoring service technicians, and other cardiac related institutions or care givers to store, retrieve, communicate and report ECG and ECG data acquired from a variety of ECG sources including single and multi-lead ECG devices, including diagnostic 12-lead devices. Users will be able to purchase specific modules for managing other patient cardiac related data such as pacemaker and rehabilitation data that fit their patients’ needs. The ECG module may be licensed to other software developers as an ECG viewer for their products. GEMS is intended for use in clinics, hospitals, physician's offices, or anywhere a medical doctor deems appropriate. GEMS does not offer diagnosis or medical alarms. It is intended that competent human intervention be involved before any impact on health occurs. Clinical judgment and experience are used to check and interpret the data.

Source page: https://510kreport.com/device/K020366
Methodology: https://510kreport.com/methodology