# K013354: Globalcardio

- Pathway: 510(k) (Traditional)
- Applicant: Cardiocomm Solutions, Inc.
- Decided: Jan 31, 2002 after 114 days
- Product code: DSH (Recorder, Magnetic Tape, Medical)
- Device class: 2
- Regulation: 21 CFR 870.2800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K945626 (1995). 6 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982384: Mercator, Harley Street Software, Ltd. (1999) Summary page 1.
- K955023: Brentwood PC-Ecg, Brentwood Medical Products, Inc. (1997) Summary page 1.

## Most influential descendants
- K033037: Modification to Globalcardio (2003), 4 descendants of its own
- K111320: Globalcardio (2011), 3 descendants of its own
- K122632: Guava II (2014), 2 descendants of its own
- K162571: Bioflux Software (2016), 1 descendant of its own
- K201040: Bioflux Software II (2020), 0 descendants of its own

## Indications for use
GlobalCardio 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 {0 store, retrieve, communicate and report ECG and ECG data acquired from a variety of ECG sources including single and multi-lead ECG devices. GlobalCardio will be accessed over the Intenet and data will be stored at either the client site or at the central GlobalCardio data warehouse. Data will'be secure, and with separate data stores for each client. Users will be able to access specific modules for managing patient cardiac related data such as arrhythmia data that fit their patients' needs. GlobalCardio is intended for use in clinics, hospitals, physician's offices, or anywhere a medical doctor deems appropriate. GlobalCardio does not offer diagnosis or medical alarms. |t 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/K013354
Methodology: https://510kreport.com/methodology