510(k) · Cleared
ClearedAvivo Mobile Patient Management System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Corventis, Inc. · DSI Detector And Alarm, Arrhythmia
Cleared on Feb 3, 2009 as substantially equivalent to K072558 (Cardionet, Inc., 2007) and 2 other predicates after an 88-day review. Its family tree reaches back 5 generations to 1988. 57 later devices descend from it.
- Decided
- Feb 3, 2009
- Review
- 88 days
- Class
- Class II
- Product code
- DSI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K882803 (1988). 10 ancestors in all. 57 later devices descend from it, 6 citing it directly.
- Root · 5 generations backK882803 ET HI-Flow Soft Tip/ET HI-Flow/Enhanced Torque STAdvanced Cardiovascular Systems, Inc. · 1988
- 4 generations backK012241 Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model…Cardionet, Inc. · 2002
- 3 generations backK052240 Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model 1002Cardionet, Inc. · 2005
- 2 generations backK063222 Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model…Cardionet, Inc. · 2006
- 1 generation backK072558 Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model…Cardionet, Inc. · 2007
- This deviceK083287 Avivo Mobile Patient Management SystemCorventis, Inc. · 2009
- Descendant · cites it directly · 40 of its ownK090696 Nuvant Cardiac Event Monitoring System; Nuvant Mobile Cardiac…Corventis, Inc. · 2009
- Descendant · cites it directly · 38 of its ownK091971 Avivo Mobile Patient Management System, Nuvant Mobile Cardiac…Corventis, Inc. · 2009
- Descendant · 2 generations on · 30 of its ownK111917 Nuvant, Mobile Cardiac TelemetryCorventis, Inc. · 2011
- Descendant · 3 generations on · 24 of its ownK113372 Nuvant, Mobilc Cardiac TelemetryCorventis, Inc. · 2012
- Descendant · 4 generations on · 23 of its ownK133701 Nuvant MCT SystemCorventis, Inc. · 2014
Showing 5 of 57 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 57 · See all- K090696Nuvant Cardiac Event Monitoring System; Nuvant Mobile Cardiac Telemetry SystemCorventis, Inc. · 2009 · cites it directly40descendants
- K091971Avivo Mobile Patient Management System, Nuvant Mobile Cardiac Telemetry (MCT) SystemCorventis, Inc. · 2009 · cites it directly38descendants
- K111917Nuvant, Mobile Cardiac TelemetryCorventis, Inc. · 2011 · 2 generations on30descendants
- K113372Nuvant, Mobilc Cardiac TelemetryCorventis, Inc. · 2012 · 3 generations on24descendants
- K133701Nuvant MCT SystemCorventis, Inc. · 2014 · 4 generations on23descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K882803 | ET HI-Flow Soft Tip/ET HI-Flow/Enhanced Torque ST | Advanced Cardiovascular Systems, Inc. | 1988 | — |
| −4 | K012241 | Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model CN1001 | Cardionet, Inc. | 2002 | — |
| −3 | K052240 | Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model 1002 | Cardionet, Inc. | 2005 | — |
| −2 | K063222 | Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model CN1004 | Cardionet, Inc. | 2006 | — |
| −1 | K072558 | Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model CN1005 | Cardionet, Inc. | 2007 | — |
| 0 (this device) | K083287 | Avivo Mobile Patient Management System | Corventis, Inc. | 2009 | — |
| +1 | K090696 | Nuvant Cardiac Event Monitoring System; Nuvant Mobile Cardiac Telemetry System | Corventis, Inc. | 2009 | — |
| +1 | K091971 | Avivo Mobile Patient Management System, Nuvant Mobile Cardiac Telemetry (MCT)… | Corventis, Inc. | 2009 | — |
| +2 | K111917 | Nuvant, Mobile Cardiac Telemetry | Corventis, Inc. | 2011 | — |
| +3 | K113372 | Nuvant, Mobilc Cardiac Telemetry | Corventis, Inc. | 2012 | — |
| +4 | K133701 | Nuvant MCT System | Corventis, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 3 | 0 |
| 2014 | 4 | 0 |
| 2015 | 3 | 0 |
| 2016 | 3 | 0 |
| 2017 | 3 | 0 |
| 2018 | 3 | 0 |
| 2019 | 3 | 0 |
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 5 | 0 |
| 2024 | 5 | 0 |
| 2025 | 7 | 0 |
| 2026 | 4 | 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 DSI? 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 DSI device
- #1 K243349 BodyGuardian Remote Monitoring System (BGRMS…score 13.1 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K072558 | Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model CN1005Summary page 1…0.1025, Product Code MHX) Class: Class II, Special Controls Predicate Devices: 1. CardioNetTM ECG Monitor with Arrhythmia Detection, K072558; DSI, "Arrhythmia Detector and Alarm", 21 CFR 870.1025 2. LifeShirtTM Real-Time, K043604; DQK, "Programmable Diagnos… | 2007 |
| * | K043604 | Lifeshirt Real-Time with Vivomonitor SoftwareSummary page 1…Devices: 1. CardioNetTM ECG Monitor with Arrhythmia Detection, K072558; DSI, "Arrhythmia Detector and Alarm", 21 CFR 870.1025 2. LifeShirtTM Real-Time, K043604; DQK, "Programmable Diagnostic Computer", 21 CFR 870.1425 3. ZOE Fluid Status Monitor, K042113; DSB, "Impedance Plet… | 2005 |
| * | K042113 | Zoe Fluid Status MonitorSummary page 1…and Alarm", 21 CFR 870.1025 2. LifeShirtTM Real-Time, K043604; DQK, "Programmable Diagnostic Computer", 21 CFR 870.1425 3. ZOE Fluid Status Monitor, K042113; DSB, "Impedance Plethysmograph", TM 21 CFR 870.2770 4. SenseWear Armband, 510(k) exempt, IKK, "Isokin-e… | 2004 |
| * | — | SenseWear Armband Named without a submission number |
What descends from it? (57)
See all 576 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090696 | Nuvant Cardiac Event Monitoring System; Nuvant Mobile Cardiac Telemetry System | 2009 | 40 |
| K091971 | Avivo Mobile Patient Management System, Nuvant Mobile Cardiac Telemetry (MCT) System | 2009 | 38 |
| K121197 | Bodyguardian System Bodyguardian Control Unit Bodyguardian Connect | 2012 | 10 |
| K142476 | Master Caution Device MCD | 2015 | 6 |
| K113187 | Avivo Mobile Patient Management | 2012 | 5 |
| K132447 | Vitalconnect Platform by Vital Connect Inc. | 2014 | 1 |
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 21 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K090696 (Corventis, Inc., 2009) has gone furthest, with 40 descendants of its own.
- 7 other devices also cite its predicate K072558.
How does its category compare?
All DSI devicesDSI Detector And Alarm, Arrhythmia: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · DSI
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DSI
243in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DSI
18in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DSI
712in 2025
MAUDE reports naming product code DSI, 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 | 7 | 151 | 4 | 64 |
| 2008 | 5 | 70 | 8 | 156 |
| 2009 | 6 | 73 | 3 | 279 |
| 2010 | 6 | 111 | 5 | 823 |
| 2011 | 6 | 114 | 3 | 793 |
| 2012 | 3 | 113 | 1 | 766 |
| 2013 | 1 | — | 0 | 795 |
| 2014 | 4 | 200 | 0 | 1,000 |
| 2015 | 9 | 127 | 0 | 1,645 |
| 2016 | 6 | 224 | 0 | 4,352 |
| 2017 | 0 | — | 0 | 3,594 |
| 2018 | 2 | — | 1 | 3,648 |
| 2019 | 3 | 243 | 4 | 3,485 |
| 2020 | 2 | — | 2 | 3,084 |
| 2021 | 0 | — | 0 | 3,092 |
| 2022 | 0 | — | 1 | 1,638 |
| 2023 | 2 | — | 2 | 1,616 |
| 2024 | 1 | — | 0 | 1,320 |
| 2025 | 1 | — | 18 | 712 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
The AVIVOTM Mobile Patient Management System is intended to continuously record, store, and periodically transmit physiological data. The System is indicated for those patients who require monitoring for the detection of non-lethal cardiac arrhythmias. The AVIVOTM Mobile Patient Management System also monitors, derives and, displays:
*ECG
- Heart Rate (including Heart Rate Variability)
- Activity
- Posture
* Body Temperature
· Respiration rate (including Respiratory Rate Variability)
· Body fluid status
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083287 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083287: Avivo Mobile Patient Management System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083287
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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