510(k) · Cleared
ClearedCoVa Monitoring System 2
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 Jun 22, 2017 as substantially equivalent to K142087 (Tosense, Inc., 2015) and 1 other predicate after a 447-day review. Its family tree reaches back 11 generations to 1988.
- Decided
- Jun 22, 2017
- Review
- 447 days
- Class
- Class II
- Product code
- MWI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to K882803 (1988). 50 ancestors in all, the oldest K872291 (1987). No later device cites it as a predicate yet.
- Root · 11 generations backK882803 ET HI-Flow Soft Tip/ET HI-Flow/Enhanced Torque STAdvanced Cardiovascular Systems, Inc. · 1988
- 7 generations between
- 3 generations backK111917 Nuvant, Mobile Cardiac TelemetryCorventis, Inc. · 2011
- 2 generations backK113187 Avivo Mobile Patient ManagementCorventis, Inc. · 2012
- 1 generation backK142087 Cova Monitoring SystemTosense, Inc. · 2015
- This deviceK160899 CoVa Monitoring System 2Tosense, Inc. · 2017
Show all 11 generations
- Root · 11 generations backK882803 ET HI-Flow Soft Tip/ET HI-Flow/Enhanced Torque STAdvanced Cardiovascular Systems, Inc. · 1988
- 10 generations backK012241 Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model…Cardionet, Inc. · 2002
- 9 generations backK052240 Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model 1002Cardionet, Inc. · 2005
- 8 generations backK063222 Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model…Cardionet, Inc. · 2006
- 7 generations backK072558 Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model…Cardionet, Inc. · 2007
- 6 generations backK083287 Avivo Mobile Patient Management SystemCorventis, Inc. · 2009
- 5 generations backK090696 Nuvant Cardiac Event Monitoring System; Nuvant Mobile Cardiac…Corventis, Inc. · 2009
- 4 generations backK091971 Avivo Mobile Patient Management System, Nuvant Mobile Cardiac…Corventis, Inc. · 2009
- 3 generations backK111917 Nuvant, Mobile Cardiac TelemetryCorventis, Inc. · 2011
- 2 generations backK113187 Avivo Mobile Patient ManagementCorventis, Inc. · 2012
- 1 generation backK142087 Cova Monitoring SystemTosense, Inc. · 2015
- This deviceK160899 CoVa Monitoring System 2Tosense, Inc. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K882803 | ET HI-Flow Soft Tip/ET HI-Flow/Enhanced Torque ST | Advanced Cardiovascular Systems, Inc. | 1988 | — |
| −10 | K012241 | Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model CN1001 | Cardionet, Inc. | 2002 | — |
| −9 | K052240 | Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model 1002 | Cardionet, Inc. | 2005 | — |
| −8 | K063222 | Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model CN1004 | Cardionet, Inc. | 2006 | — |
| −7 | K072558 | Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model CN1005 | Cardionet, Inc. | 2007 | — |
| −6 | K083287 | Avivo Mobile Patient Management System | Corventis, Inc. | 2009 | — |
| −5 | K090696 | Nuvant Cardiac Event Monitoring System; Nuvant Mobile Cardiac Telemetry System | Corventis, Inc. | 2009 | — |
| −4 | K091971 | Avivo Mobile Patient Management System, Nuvant Mobile Cardiac Telemetry (MCT)… | Corventis, Inc. | 2009 | — |
| −3 | K111917 | Nuvant, Mobile Cardiac Telemetry | Corventis, Inc. | 2011 | — |
| −2 | K113187 | Avivo Mobile Patient Management | Corventis, Inc. | 2012 | — |
| −1 | K142087 | Cova Monitoring System | Tosense, Inc. | 2015 | — |
| 0 (this device) | 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 |
| 1990 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 5 | 0 |
| 2005 | 3 | 0 |
| 2007 | 3 | 0 |
| 2008 | 3 | 0 |
| 2012 | 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? (2)
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 |
|---|---|---|---|
| * | K142087 | Cova Monitoring SystemSummary page 4…(FLL) Regulations Predicate CoVaTM Monitoring System (referred to herein as the ‘CoVaTM 1’) Devices Manufacturer: toSense, Inc. Number: K142087 Clearance Date: May 1, 2015 CardioDynamics BioZ Dx (referred to herein as the ‘BioZ monitor’)… | 2015 |
| * | K070156 | Bioz DX Hemodynamic Monitor with Philips 12-Lead Ecg, Model 5100Summary page 4…te: May 1, 2015 CardioDynamics BioZ Dx (referred to herein as the ‘BioZ monitor’) Manufacturer: CardioDynamics Number: K070156 Clearance Date: September 26, 2007 Description toSense’s CoVaTM 2 features a body-worn Sensor, Gateway, and… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
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 29 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- 3 of the 50 ancestors have a recall of any class.
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. 2017, 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 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…
Read the full statement (231 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K160899 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160899: CoVa Monitoring System 2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160899
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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