# K040942: VST3

- Pathway: 510(k) (Traditional)
- Applicant: Biowatch Medical, Inc.
- Decided: Sep 15, 2004 after 156 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: 2 generations back to K963725 (1997). 3 ancestors in all.
18 later devices descend from it; 1 cites it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012223: CG-2211 Selfcheck Ecg Transmitter, Card Guard Scientific Survival, Ltd. (2001) Summary page 1.

## Most influential descendants
- K063609: River- 1 Electrocardiograph (Ecg) Recorder and Transmitter (2007), 17 descendants of its own
- K080047: Cardiosen'c (2008), 11 descendants of its own
- K113514: Smartheart (2012), 10 descendants of its own
- K142476: Master Caution Device MCD (2015), 6 descendants of its own
- K161431: SimplECG (2016), 5 descendants of its own

## Indications for use
The Biowatch Medical VST3 is indicated for use to monitor adults with abnormal heart rhythms and other symptoms of cardiac disease, such as: * Arrhythmia or dysrhythmia * Skipped beats or pauses * Rapid, slow, or irregular heart rate * Lightheadedness or faintness * Palpitations The VST3 records and transmits ECG data to a remote central receiving station for interpretation by certified critical care specialists and/or a licensed over-read physician to identify cardiac rhythm disorders. The device is not intended to sound any alarms

Source page: https://510kreport.com/device/K040942
Methodology: https://510kreport.com/methodology