# K182030: Faros Mobile

- Pathway: 510(k) (Abbreviated)
- Applicant: Bittium Biosignals, Ltd.
- Decided: Nov 8, 2018 after 101 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: 6 generations back to K930806 (1994). 28 ancestors in all.
No later device cites it as a predicate yet.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140847: Cardiospy Ecg Holter Systems, Labtech Kft. (2014) Summary page 5.

## Indications for use
The Faros Mobile system is intended for use in clinical long term ambulatory ECG monitoring, data transfer and analysis. Faros Mobile is indicated for adult and pediatric patients who require ECG monitoring inside or outside hospital or healthcare facility environments. Faros Mobile provides the detection and reporting features appropriate for the indications below * Evaluation of patients with symptoms related to rhythm disturbances or symptoms suggesting arrhythmias. * Evaluation of patients for ST segment changes * Evaluation patients with pacemaker * Evaluating patient rest and stress ECG * Reporting heart rate variability analysis » Wireless transmission of patient ECG data and arrhythmia events for further analysis. Interpretation algorithm provides a computer-generated analysis of potential patient cardiac abnormalities, which must be confirmed by a physician with other relevant clinical information. The Faros Mobile does not provide interpretive statements. Faros Mobile is contraindicated for * Those patients requiring attended, in-hospital monitoring for life threatening arrhythmias * Pediatric patients weighting less than 10 kg

Source page: https://510kreport.com/device/K182030
Methodology: https://510kreport.com/methodology