510(k) · Cleared
ClearedAVIVO Mobile Patient Management (MPM) System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic, Inc. · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)
Cleared on Mar 30, 2016 as substantially equivalent to K113187 (Corventis, Inc., 2012) and 2 other predicates after a 149-day review. Its family tree reaches back 11 generations to 1988.
- Decided
- Mar 30, 2016
- Review
- 149 days
- Class
- Class II
- Product code
- MHX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 11 generations to K882803 (1988). 26 ancestors in all. 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 backK113372 Nuvant, Mobilc Cardiac TelemetryCorventis, Inc. · 2012
- 1 generation backK133701 Nuvant MCT SystemCorventis, Inc. · 2014
- This deviceK153160 AVIVO Mobile Patient Management (MPM) SystemMedtronic, Inc. · 2016
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 backK113372 Nuvant, Mobilc Cardiac TelemetryCorventis, Inc. · 2012
- 1 generation backK133701 Nuvant MCT SystemCorventis, Inc. · 2014
- This deviceK153160 AVIVO Mobile Patient Management (MPM) SystemMedtronic, Inc. · 2016
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 | K113372 | Nuvant, Mobilc Cardiac Telemetry | Corventis, Inc. | 2012 | — |
| −1 | K133701 | Nuvant MCT System | Corventis, Inc. | 2014 | — |
| 0 (this device) | 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 |
| 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 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? (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 |
|---|---|---|---|
| * | K113187 | Avivo Mobile Patient ManagementSummary page 4…onitor, Physiological, Patient (With Arrhythmia Detection or Alarms) Predicate Devices: Primary K113187, cleared January 4, 2012 (AVIVO™ MPM) Secondary K113372, cleared Ma… | 2012 |
| * | K113372 | Nuvant, Mobilc Cardiac TelemetrySummary page 4…Primary K113187, cleared January 4, 2012 (AVIVO™ MPM) Secondary K113372, cleared March 7, 2012 (NUVANT™ MCT) K133701, cleared February 6, 2014 (NUVANT™ MCT) -… | 2012 |
| * | K133701 | Nuvant MCT SystemSummary page 4…4, 2012 (AVIVO™ MPM) Secondary K113372, cleared March 7, 2012 (NUVANT™ MCT) K133701, cleared February 6, 2014 (NUVANT™ MCT) - rebranded as SEEQ™ MCT… | 2014 |
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 28 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- 1 of the 26 ancestors has a recall of any class.
- 2 other devices also cite its predicate K113187.
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. 2016, 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 (MPM) System is intended to continuously measure, record and periodically transmit physiological data. The AVIVO™ MPM 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…
Read the full statement (123 words)
The AVIVO™ Mobile Patient Management (MPM) System is intended to continuously measure, record and periodically transmit physiological data. The AVIVO™ MPM 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™ MPM System monitors, derives and displays:
• ECG
• Heart Rate (including HR variability)
• Activity
• Posture
• Respiration Rate (including RR variability)
• Body Fluid Status
The system has not been tested specifically for pediatric use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153160 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153160: AVIVO Mobile Patient Management (MPM) System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153160
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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