# K212662: AliveCor QT Service

- Pathway: 510(k) (Traditional)
- Applicant: AliveCor, Inc.
- Decided: Apr 26, 2022 after 246 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K200560: InBody, Inbody Co., Ltd. (2021). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
AliveCor QT Service analyses 30 seconds of a previously acquired electrocardiogram (ECG) from AliveCor designed 6-Lead ambulatory ECG devices analyzed as normal sinus rhythm for QT interval measurements. AliveCor QT Service is intended for use in a professional medical facility, such as a hospital, clinic, or doctor’s office by a qualified health care professional, including trained ECG technician. AliveCor QT Service is indicated for use on adult patients (older than 18 years). The device has not been tested for and is not intended for pediatric use. The service is not intended for use in life supporting, or sustaining systems, or continuous ECG monitors, or cardiac alarm devices, or OTC use only devices.

Source page: https://510kreport.com/device/K212662
Methodology: https://510kreport.com/methodology