# K160899: CoVa Monitoring System 2

- Pathway: 510(k) (Traditional)
- Applicant: Tosense, Inc.
- Decided: Jun 22, 2017 after 447 days
- Product code: MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.2300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K882803 (1988). 50 ancestors in all.
No later device cites it as a predicate yet.
0 of 51 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142087: Cova Monitoring System, Tosense, Inc. (2015) Summary page 4.
- K070156: Bioz DX Hemodynamic Monitor with Philips 12-Lead Ecg, Model 5100, Cardiodynamics International Corp. (2007) Summary page 4.

## Indications for use
The CoVa Monitoring System 2 is intended for adult patients under the direction of a licensed medical professional or by clinical personnel trained in its proper use. It is intended to record, store, and transmit the following physiological data: 1) heart rate including heart rate variability; ii) respiration rate; iii) thoracic impedance; iv) estimated stroke volume; v) estimated cardiac output; and vi) posture. It displays these physiological data, along with ECG and impedance waveforms, to the licensed medical professionals and/or clinical personnel. The information should be integrated into the context of all clinical data to make determinations of patient status. The CoVa Monitoring System 2 is indicated for patients with fluid-management disorders managed by regular use of diuretics, and/or suffering from a disease or medical condition characterized by an increase in fluid, such as kidney failure, heart failure, and/or edema caused by a chronic disease (e.g. heart failure) normally treated with a diuretic. The following are contraindications for the CoVa Monitoring System 2: * The System is not defibrillator-proof. Thus its Sensor should be removed from a patient before using an external defibrillator. * The System includes magnetically active materials, and thus should not be used by patients undergoing a procedure involving magnetic resonance imaging (MRI). * The System should not be used by patients diagnosed with severe cardiac arrhythmias. * The System should not be used by critically ill patients.

Source page: https://510kreport.com/device/K160899
Methodology: https://510kreport.com/methodology