# K013879: TM2000, Model 1

- Pathway: 510(k) (Traditional)
- Applicant: Card Guard Scientific Survival, Ltd.
- Decided: Feb 1, 2002 after 70 days
- Product code: DXH (Transmitters And Receivers, Electrocardiograph, Telephone)
- Device class: 2
- Regulation: 21 CFR 870.2920
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K992164 (1999). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992164: Telemedicine 2000, Card Guard Scientific Survival, Ltd. (1999) Summary page 2.

## Most influential descendants
- K021574: TM2000 Fetaltrace Transtelephonic Receiving Center (2002), 0 descendants of its own

## Indications for use
The TM2000 Telemedicine Receiving Center is intended for supporting transtelephonic monitoring of Electrocardiography (ECG), Spirometric and Fetal/Maternal parameters of patients.

Source page: https://510kreport.com/device/K013879
Methodology: https://510kreport.com/methodology