# K122632: Guava II

- Pathway: 510(k) (Traditional)
- Applicant: Cardiocomm Solutions, Inc.
- Decided: Feb 11, 2014 after 531 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: 8 generations back to K941811 (1994). 36 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111320: Globalcardio, Cardiocomm Solutions, Inc. (2011) Summary page 3.
- K062282: Monebo Automated Ecg Analysis and Interpretation Software Library, Version 3.0, Monebo Technologies, Inc. (2007) Summary page 2.

## Most influential descendants
- K162571: Bioflux Software (2016), 1 descendant of its own
- K201040: Bioflux Software II (2020), 0 descendants of its own

## Indications for use
Guava 11 is intended to be used by cardiologists, general practitioners, cardiac or ECG technicians, nurses, monitoring service technicians, and other cardiac related institutions or care givens to store, retrieve, communicate and report ECG and ECG data acquired from a variety of ECG sources including single and multilead ECG devices. Guava Illis intended to be electronically interfaced, and perform analysis with data transferred from other computer based ECG systems. Guava II includes an algorithm that will analyze the 12 Lead ECG and produce measurements of the ECG recording as well as textual interpretation. The product also includes an automatic analysis and interpretation software library that provides ECG signal processing and analysis on a beat by beat basis, QRS and Ventricular Ectopic Beat detection, QRS feature extraction, interval measurement, heart rate measurement, and rhythm analysis for up to twelve (12) leads of historic ambulatory ECG data. The Guava II algorithm analysis can detect and classify arrhythmias and may be used to triage data, however, Guava 11 is not intended to offer independent diagnosis or provide medical alarms. Clinical judgment and experience are used to check and interpret the data as part of a diagnosis. Guava Illis not for use in life-supporting or sustaining systems or EGG monitoring devices. Guava II is intended for use in clinics, hospitals, physician's offices, or anywhere a medical doctor deems appropniate.

Source page: https://510kreport.com/device/K122632
Methodology: https://510kreport.com/methodology