# K002209: GE Marquette Ecg Analysis Program

- Pathway: 510(k) (Special)
- Applicant: General Electric Medical Systems Information Techn
- Decided: Aug 18, 2000 after 28 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
87 later devices descend from it; 3 cite it directly.
0 of 88 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K014108: Mac 5000 Ecg Analysis System (2002), 71 descendants of its own
- K091513: Smart Ecg Series Electrocardiograph, Models SE-3, SE-300A and 300B, SE-6, SE-600, SE-12, SE-12 Express and SE-1200 (2009), 32 descendants of its own
- K033492: Modification to Mac 5000 Ecg Analysis System (2003), 31 descendants of its own
- K042177: Modification to Mac 5000 Ecg Analysis System (2004), 30 descendants of its own
- K031561: Cardiosoft/Case Cardiac Testing System (2003), 30 descendants of its own

Source page: https://510kreport.com/device/K002209
Methodology: https://510kreport.com/methodology