# K243566: CardioTag™

- Pathway: 510(k) (Traditional)
- Applicant: Cardiosense, Inc.
- Decided: Jul 22, 2025 after 246 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 K853124 (1985). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 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.
- K023238: Mcpulse, Meridian Co., Ltd. (2003) Summary page 5.

## Indications for use
The CardioTag device is a tool that can be used to record, display and transfer vibrational waveforms produced by the heart contractions and transmitted to the chest as well as single-channel electrocardiogram (ECG) rhythms and heart rate. It also measures pulse waveform and pulse rate by photoplethysmograph (PPG). The CardioTag may be used as a tool to measure the timing of the aortic valve opening and closing in the cardiac cycle. The CardioTag is intended for spot-checking of adult patients in clinics or at home under the care of a physician. The data from the CardioTag is intended for use by healthcare professionals as an aid to diagnosis and treatment.

Source page: https://510kreport.com/device/K243566
Methodology: https://510kreport.com/methodology