# K051730: Matrix Holter System, Model M12

- Pathway: 510(k) (Abbreviated)
- Applicant: Global Instrumentation, LLC
- Decided: Sep 26, 2005 after 91 days
- Product code: MLO (Electrocardiograph, Ambulatory, With Analysis Algorithm)
- 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 K911097 (1991). 4 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021373: H12+Holter Recorder, Mortara Instrument, Inc. (2002) Summary page 1.
- K945985: PC Holter Scanning System Simplicity, Altair 8200, 8300, 8400, Burdick, Inc. (1995) Summary page 1.
- K942565: Altair-Disc Recorder, Burdick Corp. (1994) Summary page 1.

## Cited in the summary but kept off the family tree
- K040417: Pillar Palatal Implant System, Restore Medical, Inc. (2004). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K101273: Dynamic Ecg System Model TLC5000 (2011), 1 descendant of its own
- K131897: CV3000 Holter Analysis System (2013), 0 descendants of its own

## Indications for use
The M12 Matrix Holter System is intended for use by trained operators in health facilities. The subject Device will provide the following diagnostic functions: • Acquiring, viewing, storing and printing Ambulatory ECG waveforms for up to twelve (12) leads of patient ECG waveforms through surface electrodes adhered to the body. * Using optional algorithms to generate measurements, data presentations, and graphical presentations on an advisory basis for the subject patients. These are presented for review and interpretation by the clinician based upon knowledge of the patient, the results of the physical examination, the ambulatory ECG tracings, and other clinical findings.

Source page: https://510kreport.com/device/K051730
Methodology: https://510kreport.com/methodology