# K113514: Smartheart

- Pathway: 510(k) (Traditional)
- Applicant: Shl Telemedicine International, Ltd.
- Decided: Feb 22, 2012 after 86 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: 5 generations back to K963725 (1997). 12 ancestors in all.
10 later devices descend from it; 2 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080047: Cardiosen'c, Shl Telemedicine International, Ltd. (2008) Summary page 2.

## Most influential descendants
- K142476: Master Caution Device MCD (2015), 6 descendants of its own
- K161431: SimplECG (2016), 5 descendants of its own
- K201669: SimpleSENSE (2020), 3 descendants of its own
- K180157: QT ECG (2018), 2 descendants of its own
- K220795: QT ECG (2022), 1 descendant of its own

## Indications for use
The Smartheart device is intended to condition an electrocardiographic signal so that it can be transmitted digitally via Bluetooth technology and cell-phone or communication device to a remote location. The Smart/wart device is designed to be used by a patient to transmit a 12 lead ECG and rhythm strip in real-time to enable review at a physician's office, hospital or other medical receiving center.

Source page: https://510kreport.com/device/K113514
Methodology: https://510kreport.com/methodology