510(k) · Cleared
ClearedµCor Heart Failure and Arrhythmia Management System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zoll Manufacturing Corporation · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)
Cleared on May 11, 2018 as substantially equivalent to K113187 (Corventis, Inc., 2012) and 1 other predicate after a 263-day review. Its family tree reaches back 10 generations to 1988. 1 later device descends from it.
- Decided
- May 11, 2018
- Review
- 263 days
- Class
- Class II
- Product code
- MHX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K882803 (1988). 27 ancestors in all. 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 deviceK172510 µCor Heart Failure and Arrhythmia Management SystemZoll Manufacturing Corporation · 2018
- Descendant · cites it directly · 0 of its ownK190939 ZOLL Arrhythmia Management SysyemZoll Manufacturing Corporation · 2019
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 deviceK172510 µCor Heart Failure and Arrhythmia Management SystemZoll Manufacturing Corporation · 2018
Most influential descendants
Showing 1 of 1 · See all- K190939ZOLL Arrhythmia Management SysyemZoll Manufacturing Corporation · 2019 · 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) | K172510 | µCor Heart Failure and Arrhythmia Management System | Zoll Manufacturing Corporation | 2018 | — |
| +1 | K190939 | ZOLL Arrhythmia Management Sysyem | Zoll Manufacturing Corporation | 2019 | — |
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 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K113187 | Avivo Mobile Patient ManagementSummary page 4…n: II Classification Panel: Circulatory System Devices Panel (74) Predicate Device: AVIVO Mobile Patient Management System (K113187) – Primary Predicate ZOE Fluid Status Monitor (K… | 2012 |
| * | K133301 | Zoe Fluid Status MonitorSummary page 4…Mobile Patient Management System (K113187) – Primary Predicate ZOE Fluid Status Monitor (K133301) – Secondary Predicate (used for the comparison of thoracic impedance measurement only)… | 2014 |
| † | K142087 | Cova Monitoring System | 2015 |
| † | K142915 | ZOLL X Series | 2014 |
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 |
|---|---|---|---|
| K190939 | ZOLL Arrhythmia Management Sysyem | 2019 | 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 30 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- 1 of the 27 ancestors has a recall of any class.
- Of its descendants, K190939 (Zoll Manufacturing Corporation, 2019) has gone furthest, with 0 descendants of its own.
- 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. 2018, 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 µCor Heart Failure and Arrhythmia Management System is intended to periodically record, store, and transmit Thoracic Fluid Index. The µCor Heart Failure and Arrhythmia Management System is also intended to continuously record and store, and periodically transmit ECG, Heart Rate, Respiration Rate, Activity and Posture. The data provided will aid medical professionals as they diagnose and identify various clinical conditions, events, and/or trends. The…
Read the full statement (124 words)
The µCor Heart Failure and Arrhythmia Management System is intended to periodically record, store, and transmit Thoracic Fluid Index. The µCor Heart Failure and Arrhythmia Management System is also intended to continuously record and store, and periodically transmit ECG, Heart Rate, Respiration Rate, Activity and Posture. The data provided will aid medical professionals as they diagnose and identify various clinical conditions, events, and/or trends.
The µCor Heart Failure and Arrhythmia Management System is intended for use in clinical and home settings and is indicated for patients who are 21 years of age or older:
i) Who require monitoring for the detection of non-lethal cardiac arrhythmias, such as, but not limited to, atrial fibrillation, atrial flutter, ventricular ectopy, and bradyarrhythmias; or
ii) Requiring fluid management.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172510 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172510: µCor Heart Failure and Arrhythmia 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/K172510
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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