# K101273: Dynamic Ecg System Model TLC5000

- Pathway: 510(k) (Traditional)
- Applicant: Contec Medical System Co., Ltd.
- Decided: Sep 30, 2011 after 512 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: 3 generations back to K911097 (1991). 5 ancestors in all.
1 later device descends 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)
- K051730: Matrix Holter System, Model M12, Global Instrumentation, LLC (2005) Summary page 1.

## Most influential descendants
- K131897: CV3000 Holter Analysis System (2013), 0 descendants of its own

## Indications for use
Dynamic ECG System, TLC5000, is intended to continuously acquire ambulatory ECG data for up to twelve leads. It can record the ECG data for at most twenty four hours. The ECG data obtained will be stored in the recorder first and then download to PC for analysis, reviewing and printing by a trained physician in health facilities.

Source page: https://510kreport.com/device/K101273
Methodology: https://510kreport.com/methodology