# K160656: CorSens

- Pathway: 510(k) (Traditional)
- Applicant: Corsens Medical, Ltd.
- Decided: Nov 21, 2016 after 258 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: 2 generations back to K910994 (1992). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081603: Digital Ballistocardiograph, Model DGB 300, Heartforce Medical, Inc. (2009) Summary page 5.

## Indications for use
CorSens Device records vibrational waveforms produced by the heart contractions and transmitted to the chest wall. CorSens Device may be used as a tool to measure the timing of part of the events in the cardiac cycle for adult population.

Source page: https://510kreport.com/device/K160656
Methodology: https://510kreport.com/methodology