# K982384: Mercator

- Pathway: 510(k) (Traditional)
- Applicant: Harley Street Software, Ltd.
- Decided: Jan 27, 1999 after 203 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: 2 generations back to K945626 (1995). 4 ancestors in all.
7 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)
- K964036: Cardiomagic 2000 Software, Instromedix, Inc. (1997) Summary page 1.
- K964784: Synergy Cardiology Information System (00431), Quinton, Inc. (1997) Summary page 1.
- K915632: Paceart CPTS-86/12, Paceart, Inc. (1992) Summary page 1.

## Most influential descendants
- K013354: Globalcardio (2002), 5 descendants of its own
- 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

## Indications for use
Mercator is intended to be used as a data management tool for physicians and cardiac clinics to store, retrieve, communicate and report ECG and ECG data acquired from a variety of ECG sources including Holter and Event Recorder 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. Mercator is intended for use in clinics, hospitals, physician’s offices, or anywhere a medical doctor deems appropriate. Mercator does not offer diagnosis or medical alarms.

Source page: https://510kreport.com/device/K982384
Methodology: https://510kreport.com/methodology