# K191406: KardiaMobile, KardiaStation

- Pathway: 510(k) (Traditional)
- Applicant: AliveCor, Inc.
- Decided: Jan 24, 2020 after 241 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: 1 generation back to DEN180044 (2018). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182396: KardiaMobile, KardiaStation, AliveCor, Inc. (2019) Summary page 4.
- DEN180044: ECG App, Apple, Inc. (2018) Summary page 4.

## Most influential descendants
- K211668: KardiaMobile Card (2021), 0 descendants of its own
- K202228: Omron Model BP7900 Blood Pressure Monitor + EKG (2021), 0 descendants of its own

## Indications for use
The KardiaMobile System is intended to record, store and transfer single-channel electrocardiogram (ECG) rhythms. The KardiaMobile System also displays ECG rhythms and output of ECG analysis from AliveCor's KardiaAI platform including detecting the presence of normal sinus rhythm, atrial fibrillation, bradycardia, tachycardia, and others. The KardiaMobile System is intended for use by healthcare professionals, patients with known or suspected heart conditions and health conscious individuals. The device has not been tested and is not intended for pediatric use.

Source page: https://510kreport.com/device/K191406
Methodology: https://510kreport.com/methodology