# K071391: Philips Heartstart 12 Lead Transfer Station, Model 989803142521

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems, Inc.
- Decided: Sep 7, 2007 after 112 days
- Product code: MSX (System, Network And Communication, Physiological Monitors)
- Device class: 2
- Regulation: 21 CFR 870.2300
- 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 K840932 (1984). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032103: Philips Tracemaster Ecg Management System, Models M5100A and M5101A, Philips Medical Systems (2003) Summary page 2.

## Indications for use
The HeartStart 12 Lead Transfer Station SW provides a diagnostic 12 lead ECG interface between Philips defibrillators and ECG management systems that can process XML formatted ECGs, such as the TraceMasterVue ECG Management system. The HeartStart 12 Lead Transfer Station application also allows viewing, printing, archiving and further distribution of digitized ECG records.

Source page: https://510kreport.com/device/K071391
Methodology: https://510kreport.com/methodology