# K132437: Mars Holter Analysis Workstation

- Pathway: 510(k) (Special)
- Applicant: Ge Medical Systems Information Technologies, Inc.
- Decided: Dec 4, 2013 after 121 days
- Product code: DQK (Computer, Diagnostic, Programmable)
- Device class: 2
- Regulation: 21 CFR 870.1425
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K930806 (1994). 10 ancestors in all.
6 later devices descend from it; 3 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093141: Mars Holter Analysis Workstation, Ge Medical Systems Information Technologies (2009) Summary page 2.

## Most influential descendants
- K151787: Holter System (2016), 2 descendants of its own
- K162023: CardioDay V2.5 (2017), 1 descendant of its own
- K254119: Wearable ECG Recorder (YMHeart XY-12); Wearable ECG Recorder (YMHeart XY-1201); Wearable ECG Recorder (YMHeart XY-1202); Wearable ECG Recorder (YMHeart XY-1203); Wearable ECG Recorder (YMHeart XY-03); Wearable ECG Recorder (YMHeart XY-0301); Wearable ECG Recorder (YMHeart XY-0302); Wearable ECG Recorder (YMHeart XY-0303) (2026), 0 descendants of its own
- K251591: Holter ECG and ABP system (HolterABP) (2026), 0 descendants of its own
- K242583: AT-Patch (ATP-C130/ATP-C70) (2025), 0 descendants of its own

## Indications for use
MIARS Halter Analysis Workstation isdesigned for acquisition, analysis, edit, review, report and storage of ambulatory ECG and multi-parameter data. Results of the automated analysis are intended to assist the physician Inthe interpretation of the recorded data. This information is not intended to serve as a substitute for the physician overread of the recorded ECG data. The MARS Halter Analysis Workstation is intended to be used by trained operators under the direct supervision of a licensed healthcare practitioner Ina hospital or clinic environment. Patient population includes both adult and pediatric (greater than I 1(g) human patients. The MARS Hotter Analysis Workstation provides the user arrhythmia studies and Halter analysis capabilities. Data acquired may be used for the following indications: * Evaluation of symptoms that may be caused by cardiac arrhythmia and/or conduction disturbances * Evaluation of symptoms that may be due to myocardial ischemla * Detection of ECG events that alter prognosis in certain forms of heart disease * Detection and analysis of pacemaker function and failure * Determination of cardiac response to lifestyle * Evaluation of therapeutic interventions * Investigations In epidemiology and clinical trials

Source page: https://510kreport.com/device/K132437
Methodology: https://510kreport.com/methodology