# K240794: Frontier X Plus

- Pathway: 510(k) (Traditional)
- Applicant: Fourth Frontier Technologies Pvt, Ltd.
- Decided: Nov 8, 2024 after 231 days
- Product code: MLO (Electrocardiograph, Ambulatory, With Analysis Algorithm)
- Device class: 2
- Regulation: 21 CFR 870.2800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K121319 (2012). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201644: QardioCore, Qardio, Inc. (2021) Summary page 5.
- K182396: KardiaMobile, KardiaStation, AliveCor, Inc. (2019) Summary page 5.

## Indications for use
The Frontier X Plus device is an ambulatory monitoring device intended to record, store, and transfer single-channel (ECG) rhythms for monitoring and evaluation. The Frontier X Plus system also displays ECG waveforms and ECG rhythm analysis; detecting the presence of normal sinus rhythm, atrial fibrillation, bradycardia, tachycardia, inconclusive and unreadable rhythm. The Frontier X Plus is intended for use by healthcare professionals, patients with known or suspected heart conditions and health-conscious individuals. It is indicated for use on adult patients who may be asymptomatic or who may suffer from transient symptoms requiring cardiac monitoring. The device has not been tested for pediatric use. The Frontier X Plus is a prescription-only device, and the reported information is provided for review by a physician who will render a diagnosis based on clinical judgment and experience.

Source page: https://510kreport.com/device/K240794
Methodology: https://510kreport.com/methodology