# K032103: Philips Tracemaster Ecg Management System, Models M5100A and M5101A

- Pathway: 510(k) (Special)
- Applicant: Philips Medical Systems
- Decided: Jul 22, 2003 after 14 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 K840932 (1984). 2 ancestors in all.
15 later devices descend from it; 2 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974420: M1730B Tracemaster Ecg System, M1766B Local Edit Station, M1798B Remote Edit Station, Hewlett-Packard Co. (1998) Summary page 1.

## Most influential descendants
- K050858: Ascentia Heartstation Ecg Management System (2005), 13 descendants of its own
- K061905: Horizon Cardiology Ecg-Mckesson's Ecg Management System, Model 1.0 (2006), 8 descendants of its own
- K113515: Horizon Cardiology Ecg Management (2012), 7 descendants of its own
- K133534: Mckesson Cardiology Ecg Mobile (2014), 6 descendants of its own
- K151774: CARESTREAM Vue Motion (2015), 4 descendants of its own

## Indications for use
The TraceMaster ECG System is a computer system which allows viewing, manual editing, printing, and archiving of digitized ECG records.

Source page: https://510kreport.com/device/K032103
Methodology: https://510kreport.com/methodology