# K142087: Cova Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Tosense, Inc.
- Decided: May 1, 2015 after 275 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: 10 generations back to K882803 (1988). 35 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042113: Zoe Fluid Status Monitor, Noninvasive Medical Technologies, LLC (2004) Summary page 4.
- K113187: Avivo Mobile Patient Management, Corventis, Inc. (2012) Summary page 4.
- K112478: Visi Mobile Monitoring System, Sotera Wireless, Inc. (2012) Summary page 4.

## Most influential descendants
- K160899: CoVa Monitoring System 2 (2017), 0 descendants of its own

## Indications for use
The CoVaTM Monitoring System is intended for use under the direction of a licensed medical professional by adult patients at home to record, store, and transmit the following physiological data: i) Heart Rate including Heart Rate Variability; ii) Thoracic Impedance; iii) Respiration Rate; and iv) Posture. The CoVaTM Monitoring System only displays these physiological data to licensed medical professionals. The CoVaTM Monitoring System is indicated for patients: i) with fluid-management problems; ii) taking diuretic medication; iii) living with heart failure; iv) living with end-stage renal disease; v) recovering from a coronary artery disease-related event; and/or vi) suffering from recurrent dehydration.

Source page: https://510kreport.com/device/K142087
Methodology: https://510kreport.com/methodology