# K181823: KardiaAI

- Pathway: 510(k) (Traditional)
- Applicant: AliveCor, Inc.
- Decided: Mar 11, 2019 after 245 days
- Product code: DQK (Computer, Diagnostic, Programmable)
- Device class: 2
- Regulation: 21 CFR 870.1425
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K963725 (1997). 19 ancestors in all.
6 later devices descend from it; 3 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171816: Kardia Band System, AliveCor, Inc. (2017) Summary page 5.
- K170568: CardioLogs ECG Analysis Platform, Cardiologs Technologies (2017) Summary page 5.

## Most influential descendants
- K183319: Triangle System (2019), 3 descendants of its own
- 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
- K200884: B-Secur HeartKey Software Library (2020), 0 descendants of its own

## Indications for use
The KardiaAl is a software analysis library intended to assess ambulatory electrocardiogram (ECG) rhythms from adult subjects. The device supports analyzing data recorded in compatible formats from any ambulatory ECG devices such as event recorders, or other similar devices. The library is intended to be integrated into other device software. The library is not intended for use in life supporting, or sustaining systems, or ECG monitors, or cardiac alarm, or OTC use only devices. The KardiaAl library provides the following capabilities: ECG noise filtering, heart rate measurement from ECGs, detection of noisy ECGs, and ECG rhythm analysis for detecting the presence of normal sinus rhythm, atrial fibrillation, bradycardia, and tachycardia (when prescribed or used under the care of a physician).

Source page: https://510kreport.com/device/K181823
Methodology: https://510kreport.com/methodology