# K182040: Coala Heart Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Coala Life AB
- Decided: Feb 8, 2019 after 193 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: 6 generations back to K963725 (1997). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142743: AliveCor Heart Monitor, AliveCor, Inc. (2015) Summary page 4.
- K170874: Eko Model E5 System (EME5), Eko DUO, Eko Devices, Inc. (2017) Summary page 4.
- K083903: 3M Littmann Electronic Stethoscope, Model 3200, 3M Company (2009) Summary page 4.

## Indications for use
The Coala Heart Monitor is intended to record, store and transfer single-channel electrocardiogram (ECG) rhythms and heart sound. The Coala Heart Monitor also displays ECG rhythms and detects the presence of normal sinus rhythm and atrial fibrillation (when prescribed or used under the care of a physician). The Coala Heart Monitor is intended for use by healthcare professionals and adults with known or suspected heart conditions. Rx ONLY.

Source page: https://510kreport.com/device/K182040
Methodology: https://510kreport.com/methodology