# K043380: Monebo Automatic Arrhythmia Detection Software Library, Version 1

- Pathway: 510(k) (Traditional)
- Applicant: Monebo Technologies, Inc.
- Decided: Apr 26, 2005 after 139 days
- Product code: DPS (Electrocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2340
- 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 K003621 (2000). 2 ancestors in all.
71 later devices descend from it; 1 cites it directly.
0 of 74 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003621: ST/AR ST and Arrhythmia Software, Model Release D.0, Agilent Technologies, Inc. (2000) Summary page 1.
- K013717: Brentwood Real Time ST and Arrhythmia Analysis Software Library, Brentwood Medical Technology Corp. (2002) Summary page 1.

## Most influential descendants
- K062282: Monebo Automated Ecg Analysis and Interpretation Software Library, Version 3.0 (2007), 70 descendants of its own
- K091075: Zeus (Zio Ecg Utilization Service) System (2009), 32 descendants of its own
- K142681: ZEUS (ZIO ECG Utilization Service) System (2014), 31 descendants of its own
- K143513: ZIO SR ECG Monitoring Service (2015), 30 descendants of its own
- K170568: CardioLogs ECG Analysis Platform (2017), 26 descendants of its own

## Indications for use
The Automatic Arrhythmia Detection Software Library is intended for use by qualified medical professionals for assessing historic ambulatory ECG data. The product allows downloading and analyzing data recorded in compatible format by Holter or Event monitoring devices. The Automatic Arrhythmia Detection Software Library provides ECG signal processing and analysis on a beat by beat basis, QRS and Ventricular Ectopic Beat detection, and QRS feature extraction. The product can be integrated into computerized ECG monitoring devices. In this case the medical device manufacturer will identify the indication for use depending on the application of their device.

Source page: https://510kreport.com/device/K043380
Methodology: https://510kreport.com/methodology