# K053378: Loop Recorder  Vitaphone, 3100 Series

- Pathway: 510(k) (Traditional)
- Applicant: Tms Telemedizinische Systeme GmbH
- Decided: Feb 23, 2006 after 80 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: 3 generations back to K963725 (1997). 11 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042469: Braemar ER800 Series Enhanced Algorithm Event Recorder, Braemar, Inc. (2004) Summary page 1.
- K020825: King of Hearts Express + AF Monitor, Card Guard Scientific Survival, Ltd. (2002) Summary page 1.
- K050670: Sensor Mobile SM 100 Vitaphone 1001R Remos, Tms Telemedizinische Systeme GmbH (2005) Summary page 1.
- K042254: PMP4 Selfcheck Ecg, Card Guard Scientific Survival, Ltd. (2005) Summary page 1.

## Most influential descendants
- K100383: Vitaphone. Model 100 BT (2010), 1 descendant of its own
- K151013: Vitaphone Tele ECG Loop Recorder (2015), 0 descendants of its own

## Indications for use
Diagnostic evaluation of patients with asymptomatic and symptomatic disturbances of the cardiac rhythm such as: - Dizziness - Heart race - Palpitations - Syncopes of unknown cause

Source page: https://510kreport.com/device/K053378
Methodology: https://510kreport.com/methodology