510(k) · Cleared
ClearedCova Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tosense, Inc. · MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Cleared on May 1, 2015 as substantially equivalent to K042113 (Noninvasive Medical Technologies, LLC, 2004) and 2 other predicates after a 275-day review. Its family tree reaches back 10 generations to 1988. 1 later device descends from it.
- Decided
- May 1, 2015
- Review
- 275 days
- Class
- Class II
- Product code
- MWI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 10 generations to K882803 (1988). 35 ancestors in all, the oldest K872291 (1987). 1 later device descends from it, 1 citing it directly.
- Root · 10 generations backK882803 ET HI-Flow Soft Tip/ET HI-Flow/Enhanced Torque STAdvanced Cardiovascular Systems, Inc. · 1988
- 6 generations between
- 3 generations backK091971 Avivo Mobile Patient Management System, Nuvant Mobile Cardiac…Corventis, Inc. · 2009
- 2 generations backK111917 Nuvant, Mobile Cardiac TelemetryCorventis, Inc. · 2011
- 1 generation backK113187 Avivo Mobile Patient ManagementCorventis, Inc. · 2012
- This deviceK142087 Cova Monitoring SystemTosense, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK160899 CoVa Monitoring System 2Tosense, Inc. · 2017
Show all 10 generations
- Root · 10 generations backK882803 ET HI-Flow Soft Tip/ET HI-Flow/Enhanced Torque STAdvanced Cardiovascular Systems, Inc. · 1988
- 9 generations backK012241 Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model…Cardionet, Inc. · 2002
- 8 generations backK052240 Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model 1002Cardionet, Inc. · 2005
- 7 generations backK063222 Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model…Cardionet, Inc. · 2006
- 6 generations backK072558 Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model…Cardionet, Inc. · 2007
- 5 generations backK083287 Avivo Mobile Patient Management SystemCorventis, Inc. · 2009
- 4 generations backK090696 Nuvant Cardiac Event Monitoring System; Nuvant Mobile Cardiac…Corventis, Inc. · 2009
- 3 generations backK091971 Avivo Mobile Patient Management System, Nuvant Mobile Cardiac…Corventis, Inc. · 2009
- 2 generations backK111917 Nuvant, Mobile Cardiac TelemetryCorventis, Inc. · 2011
- 1 generation backK113187 Avivo Mobile Patient ManagementCorventis, Inc. · 2012
- This deviceK142087 Cova Monitoring SystemTosense, Inc. · 2015
Most influential descendants
Showing 1 of 1 · See all- K160899CoVa Monitoring System 2Tosense, Inc. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K882803 | ET HI-Flow Soft Tip/ET HI-Flow/Enhanced Torque ST | Advanced Cardiovascular Systems, Inc. | 1988 | — |
| −9 | K012241 | Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model CN1001 | Cardionet, Inc. | 2002 | — |
| −8 | K052240 | Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model 1002 | Cardionet, Inc. | 2005 | — |
| −7 | K063222 | Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model CN1004 | Cardionet, Inc. | 2006 | — |
| −6 | K072558 | Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model CN1005 | Cardionet, Inc. | 2007 | — |
| −5 | K083287 | Avivo Mobile Patient Management System | Corventis, Inc. | 2009 | — |
| −4 | K090696 | Nuvant Cardiac Event Monitoring System; Nuvant Mobile Cardiac Telemetry System | Corventis, Inc. | 2009 | — |
| −3 | K091971 | Avivo Mobile Patient Management System, Nuvant Mobile Cardiac Telemetry (MCT)… | Corventis, Inc. | 2009 | — |
| −2 | K111917 | Nuvant, Mobile Cardiac Telemetry | Corventis, Inc. | 2011 | — |
| −1 | K113187 | Avivo Mobile Patient Management | Corventis, Inc. | 2012 | — |
| 0 (this device) | K142087 | Cova Monitoring System | Tosense, Inc. | 2015 | — |
| +1 | K160899 | CoVa Monitoring System 2 | Tosense, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MWI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MWI device
- #1 K230457 Empatica Health Monitoring Platform…score 28.0 · 39 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K042113 | Zoe Fluid Status MonitorSummary page 4…edicate Zoe Fluid Status Monitor (referred to herein as the ‘Zoe monitor’) Devices Manufacturer: Non-Invasive Technologies, Inc. Number: K042113 Clearance Date: September 14, 2004 Avivo Mobile Patient Management System (referred to herein a… | 2004 |
| * | K113187 | Avivo Mobile Patient ManagementSummary page 4…Avivo Mobile Patient Management System (referred to herein as the ‘Corventis monitor’) Manufacturer: Corventis Number: K113187 Clearance Date: January 4, 2012 ViSi Mobile Monitoring System (referred to herein as the ‘ViSi… | 2012 |
| * | K112478 | Visi Mobile Monitoring SystemSummary page 4…4, 2012 ViSi Mobile Monitoring System (referred to herein as the ‘ViSi monitor’) Manufacturer: Sotera Wireless Number: K112478 Clearance Date: March 22, 2012 Description toSense’s CoVaTM Monitoring System features a body-worn Sensor,… | 2012 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K160899 | CoVa Monitoring System 2 | 2017 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 27 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- 2 of the 35 ancestors have a recall of any class.
- Of its descendants, K160899 (Tosense, Inc., 2017) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K042113.
How does its category compare?
All MWI devicesMWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms): FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · MWI
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MWI
247in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MWI
9so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MWI
182in 2025
MAUDE reports naming product code MWI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 9 | 42 | 1 | 3 |
| 2008 | 9 | 49 | 1 | 3 |
| 2009 | 6 | 112 | 2 | 20 |
| 2010 | 17 | 58 | 2 | 17 |
| 2011 | 11 | 78 | 3 | 16 |
| 2012 | 13 | 104 | 5 | 31 |
| 2013 | 20 | 85 | 3 | 42 |
| 2014 | 16 | 148 | 6 | 30 |
| 2015 | 19 | 127 | 1 | 31 |
| 2016 | 12 | 165 | 0 | 51 |
| 2017 | 13 | 205 | 2 | 85 |
| 2018 | 11 | 217 | 0 | 158 |
| 2019 | 14 | 255 | 4 | 169 |
| 2020 | 8 | 138 | 0 | 110 |
| 2021 | 9 | 161 | 0 | 188 |
| 2022 | 5 | 231 | 2 | 168 |
| 2023 | 8 | 250 | 0 | 179 |
| 2024 | 10 | 202 | 5 | 120 |
| 2025 | 4 | 247 | 0 | 182 |
| 2026 | 6 | 239 | 9 | — |
What is it indicated for?
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…
Read the full statement (100 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142087 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142087: Cova Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142087
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026