# K201985: KardiaAI

- Pathway: 510(k) (Traditional)
- Applicant: AliveCor, Inc.
- Decided: Nov 12, 2020 after 118 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: 8 generations back to K963725 (1997). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181823: KardiaAI, AliveCor, Inc. (2019) Summary page 4.

## Indications for use
KardiaAI is a software analysis library intended to assess ambulatory electrocardiogram (ECG) rhythms from adult subjects (when prescribed or used under the care of a physician). 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 KardiaAI library provides the following capabilities: • Filtering ECG noise, • Reporting heart rate measurement from ECGs, • Detecting noisy ECGs, • Reporting ECG rhythm analysis for the presence of sinus rhythm, atrial fibrillation, bradycardia, and tachycardia; for ECGs detected as sinus rhythm, detecting normal sinus rhythm, sinus rhythm with wide QRS, sinus rhythm with premature ventricular contractions (PVC), and sinus rhythm with supraventricular ectopy, • Detecting QRS complexes in an ECG, • For ECGs detected as sinus rhythm, classifying individual beats as a PVC or non-PVC beat, and • Generating an average beat from an ECG The device is not intended for use in patients who have pacemakers, ICDs, or other implanted electronic devices.

Source page: https://510kreport.com/device/K201985
Methodology: https://510kreport.com/methodology