# K081603: Digital Ballistocardiograph, Model DGB 300

- Pathway: 510(k) (Traditional)
- Applicant: Heartforce Medical, Inc.
- Decided: Jul 24, 2009 after 413 days
- Product code: DXR (Ballistocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2320
- 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 K910994 (1992). 1 ancestor in all.
4 later devices descend from it; 3 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K910994: Modified Seismocardiograph, Seismed Instruments, Inc. (1992) Summary page 1.

## Most influential descendants
- K143432: Cardio-TriTest (2015), 1 descendant of its own
- K243566: CardioTag™ (2025), 0 descendants of its own
- K182790: Cardio-TriTest v6.5 (2018), 0 descendants of its own
- K160656: CorSens (2016), 0 descendants of its own

## Indications for use
The dBG 300 records vibrational waveforms produced by the hearts contractions and transmitted to the chest wall. The dBG 300 may be used as a tool to measure the timing of the events in the cardiac cycle.

Source page: https://510kreport.com/device/K081603
Methodology: https://510kreport.com/methodology