510(k) · Cleared
ClearedAvivo Mobile Patient Management
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Corventis, Inc. · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)
Cleared on Jan 4, 2012 as substantially equivalent to K083287 (Corventis, Inc., 2009) and 4 other predicates after a 65-day review. Its family tree reaches back 9 generations to 1988. 5 later devices descend from it.
- Decided
- Jan 4, 2012
- Review
- 65 days
- Class
- Class II
- Product code
- MHX
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 9 generations to K882803 (1988). 23 ancestors in all. 5 later devices descend from it, 3 citing it directly.
- Root · 9 generations backK882803 ET HI-Flow Soft Tip/ET HI-Flow/Enhanced Torque STAdvanced Cardiovascular Systems, Inc. · 1988
- 5 generations between
- 3 generations backK090696 Nuvant Cardiac Event Monitoring System; Nuvant Mobile Cardiac…Corventis, Inc. · 2009
- 2 generations backK091971 Avivo Mobile Patient Management System, Nuvant Mobile Cardiac…Corventis, Inc. · 2009
- 1 generation backK111917 Nuvant, Mobile Cardiac TelemetryCorventis, Inc. · 2011
- This deviceK113187 Avivo Mobile Patient ManagementCorventis, Inc. · 2012
- Descendant · cites it directly · 1 of its ownK172510 µCor Heart Failure and Arrhythmia Management SystemZoll Manufacturing Corporation · 2018
- Descendant · cites it directly · 1 of its ownK142087 Cova Monitoring SystemTosense, Inc. · 2015
- Descendant · 2 generations on · 0 of its ownK190939 ZOLL Arrhythmia Management SysyemZoll Manufacturing Corporation · 2019
- Descendant · 2 generations on · 0 of its ownK160899 CoVa Monitoring System 2Tosense, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK153160 AVIVO Mobile Patient Management (MPM) SystemMedtronic, Inc. · 2016
Show all 9 generations
- Root · 9 generations backK882803 ET HI-Flow Soft Tip/ET HI-Flow/Enhanced Torque STAdvanced Cardiovascular Systems, Inc. · 1988
- 8 generations backK012241 Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model…Cardionet, Inc. · 2002
- 7 generations backK052240 Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model 1002Cardionet, Inc. · 2005
- 6 generations backK063222 Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model…Cardionet, Inc. · 2006
- 5 generations backK072558 Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model…Cardionet, Inc. · 2007
- 4 generations backK083287 Avivo Mobile Patient Management SystemCorventis, Inc. · 2009
- 3 generations backK090696 Nuvant Cardiac Event Monitoring System; Nuvant Mobile Cardiac…Corventis, Inc. · 2009
- 2 generations backK091971 Avivo Mobile Patient Management System, Nuvant Mobile Cardiac…Corventis, Inc. · 2009
- 1 generation backK111917 Nuvant, Mobile Cardiac TelemetryCorventis, Inc. · 2011
- This deviceK113187 Avivo Mobile Patient ManagementCorventis, Inc. · 2012
Most influential descendants
Showing 5 of 5 · See all- K172510µCor Heart Failure and Arrhythmia Management SystemZoll Manufacturing Corporation · 2018 · cites it directly1descendant
- K142087Cova Monitoring SystemTosense, Inc. · 2015 · cites it directly1descendant
- K190939ZOLL Arrhythmia Management SysyemZoll Manufacturing Corporation · 2019 · 2 generations on0descendants
- K160899CoVa Monitoring System 2Tosense, Inc. · 2017 · 2 generations on0descendants
- K153160AVIVO Mobile Patient Management (MPM) SystemMedtronic, Inc. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K882803 | ET HI-Flow Soft Tip/ET HI-Flow/Enhanced Torque ST | Advanced Cardiovascular Systems, Inc. | 1988 | — |
| −8 | K012241 | Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model CN1001 | Cardionet, Inc. | 2002 | — |
| −7 | K052240 | Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model 1002 | Cardionet, Inc. | 2005 | — |
| −6 | K063222 | Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model CN1004 | Cardionet, Inc. | 2006 | — |
| −5 | K072558 | Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model CN1005 | Cardionet, Inc. | 2007 | — |
| −4 | K083287 | Avivo Mobile Patient Management System | Corventis, Inc. | 2009 | — |
| −3 | K090696 | Nuvant Cardiac Event Monitoring System; Nuvant Mobile Cardiac Telemetry System | Corventis, Inc. | 2009 | — |
| −2 | K091971 | Avivo Mobile Patient Management System, Nuvant Mobile Cardiac Telemetry (MCT)… | Corventis, Inc. | 2009 | — |
| −1 | K111917 | Nuvant, Mobile Cardiac Telemetry | Corventis, Inc. | 2011 | — |
| 0 (this device) | K113187 | Avivo Mobile Patient Management | Corventis, Inc. | 2012 | — |
| +1 | K172510 | µCor Heart Failure and Arrhythmia Management System | Zoll Manufacturing Corporation | 2018 | — |
| +1 | K142087 | Cova Monitoring System | Tosense, Inc. | 2015 | — |
| +2 | K190939 | ZOLL Arrhythmia Management Sysyem | Zoll Manufacturing Corporation | 2019 | — |
| +2 | K160899 | CoVa Monitoring System 2 | Tosense, Inc. | 2017 | — |
| +1 | K153160 | AVIVO Mobile Patient Management (MPM) System | Medtronic, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 3 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2008 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 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 MHX? 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 MHX device
- #1 K251702 IntelliVue Patient Monitor MX750; IntelliVue…score 23.0 · 40 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K083287 | Avivo Mobile Patient Management SystemSummary page 1…October 28, 2011 Predicate Devices: 1. AVIVO Mobile Patient Management System, Corventis, Inc. cleared by FDA under 510(k) numbers K083287, K090696, and K091971; 21 CFR 870.1025, DSI "Arrhythmia Detector and Alarm", and 21 CFH 870.1025, MHX "Patient Phys… | 2009 |
| * | K090696 | Nuvant Cardiac Event Monitoring System; Nuvant Mobile Cardiac Telemetry SystemSummary page 1…October 28, 2011 Predicate Devices: 1. AVIVO Mobile Patient Management System, Corventis, Inc. cleared by FDA under 510(k) numbers K083287, K090696, and K091971; 21 CFR 870.1025, DSI "Arrhythmia Detector and Alarm", and 21 CFH 870.1025, MHX "Patient Physiological… | 2009 |
| * | K091971 | Avivo Mobile Patient Management System, Nuvant Mobile Cardiac Telemetry (MCT) SystemSummary page 1…October 28, 2011 Predicate Devices: 1. AVIVO Mobile Patient Management System, Corventis, Inc. cleared by FDA under 510(k) numbers K083287, K090696, and K091971; 21 CFR 870.1025, DSI "Arrhythmia Detector and Alarm", and 21 CFH 870.1025, MHX "Patient Physiological Monitor (wit… | 2009 |
| * | K111917 | Nuvant, Mobile Cardiac TelemetrySummary page 1…Monitor (with arrhythmia dletection)" 2. NUVANTO Mobile Cardiac Telemetry System, Corventis, Inc. cleared by FDA under 510(k) number K(090696, K(091971, and K(111917; 21 CFR 870.1025, DSI "Arrhythmia Detector and Alarm", and 21 CFR 870.1025, MHX "Patient Physiological Monitor (wit… | 2011 |
| * | K042113 | Zoe Fluid Status MonitorSummary page 1…X "Patient Physiological Monitor (with arrhythmia detection)" 3. ZOE Fluid Status Monitor, Noninvasive Medical Technologies, IL, cleared by FDA under K(042113; 21 CIFR 870.2770, DSB "Impedance Plethysmograph" Section 7: Summary of Safety and Effectiveness… | 2004 |
What descends from it? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 24 years and passes through 3 companies; a new generation was cleared every 1.1 years on median.
- 1 of the 23 ancestors has a recall of any class.
- Of its descendants, K172510 (Zoll Manufacturing Corporation, 2018) has gone furthest, with 1 descendant of its own.
- 5 other devices also cite its predicate K083287.
How does its category compare?
All MHX devicesMHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms): FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · MHX
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MHX
192in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MHX
21so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MHX
3,761in 2025
MAUDE reports naming product code MHX, 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 | 15 | 96 | 3 | 131 |
| 2008 | 16 | 58 | 2 | 232 |
| 2009 | 13 | 57 | 7 | 382 |
| 2010 | 20 | 90 | 13 | 955 |
| 2011 | 12 | 81 | 16 | 949 |
| 2012 | 16 | 88 | 11 | 676 |
| 2013 | 21 | 120 | 14 | 1,997 |
| 2014 | 13 | 248 | 6 | 1,609 |
| 2015 | 14 | 203 | 5 | 1,284 |
| 2016 | 13 | 149 | 7 | 1,105 |
| 2017 | 14 | 134 | 6 | 1,115 |
| 2018 | 11 | 203 | 12 | 2,157 |
| 2019 | 7 | 243 | 6 | 1,462 |
| 2020 | 11 | 196 | 0 | 1,714 |
| 2021 | 5 | 195 | 0 | 2,423 |
| 2022 | 15 | 189 | 6 | 1,470 |
| 2023 | 8 | 229 | 3 | 2,254 |
| 2024 | 5 | 181 | 3 | 2,814 |
| 2025 | 8 | 192 | 15 | 3,761 |
| 2026 | 14 | 205 | 21 | — |
What is it indicated for?
The AVIVO Mobile Patient Management System is intended to continuously record, store, and periodically transmit physiological data. The System is indicated for patients: * with fluid management problems * taking diuretic medication * living with heart failure * living with end-stage renal disease * suffering from recurrent dehydration * who require monitoring for the detection of non-lethal cardiac arrhythmias such as, but not limited to…
Read the full statement (113 words)
The AVIVO Mobile Patient Management System is intended to continuously record, store, and periodically transmit physiological data. The System is indicated for patients:
* with fluid management problems
* taking diuretic medication
* living with heart failure
* living with end-stage renal disease
* suffering from recurrent dehydration
* who require monitoring for the detection of non-lethal cardiac arrhythmias such as, but not limited to, supraventricular tachycardias (e.g. atrial fibrillation, atrial flutter, paroxysmal SVTs), ventricular ectopy, bradyarrhythmias and conduction disorders.
The AVIVO Mobile Patient Management System also monitors, derives and displays:
* ECG
* Heart Rate (including HR variability)
* Activity
* Posture
* Respiration rate (including RR variability)
* Body fluid status
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113187 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113187: Avivo Mobile Patient Management.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113187
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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