# K183319: Triangle System

- Pathway: 510(k) (Traditional)
- Applicant: AliveCor, Inc.
- Decided: May 10, 2019 after 161 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: 8 generations back to K963725 (1997). 21 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142672: AliveCor Heart Monitor, AliveCor, Inc. (2014) Summary page 5.
- K181823: KardiaAI, AliveCor, Inc. (2019). Cleared while this submission was under review Summary page 5.

## Most influential descendants
- K210753: KardiaMobile 6L (2021), 2 descendants of its own
- K231424: HeartBeam AIMIGo (TM) System (2024), 0 descendants of its own
- K220350: KardiaMobile 6L (2022), 0 descendants of its own

## Indications for use
The Triangle System is intended to record, store and transfer one- and two-channel electrocardiogram (ECG) rhythms. In single channel mode, the Triangle System can record Lead-I. In two channel mode, the Triangle System can record Lead-I and Lead-II simultaneously and derive Lead-III and unipolar limb leads aVR, aVF and aVL. The Triangle 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 Triangle 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/K183319
Methodology: https://510kreport.com/methodology